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Respironics Life Nasal Mask Premarket Notification Special 510(k) TAB3 K DEC 222010 510(K) SUMMARY Date of Submission 51 0(k) Owner 30 August 2010 Respironics, Inc. 1001 Murry Ridge Lane Marysville,.

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How to access the FDA 510(k) Database. The FDA's database of 510(k) premarket notifications is available for public access on the department's official website.

Overview. A submitter may choose from three types of Premarket Notification 510(k) submissions to seek marketing clearance for their device when appropriate for review under the 510(k) Program: Traditional, Special, and Abbreviated. The Traditional Program is the original submission type as provided in 21 CFR 807.

The most common types of premarket submissions include: 510(k) (Premarket Notification) PMA (Premarket Approval) De Novo Classification Request. HDE (Humanitarian Device Exemption)

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

There is also no special “form” to complete, a traditional 510(k) is simply a submission of all the information required under 21 CFR 807.87. A special 510(k) is commonly used when you want to make a change or modification to a device already on the market.

Devices are classified into 3 groups by the FDA: Class I or “low risk of illness or injury” (e.g., surgical gauze [9]); Class II or “moderate risk” (e.g., suture [10]); and Class III, those which “support or sustain human life, are of substantial importance in preventing impairment of human health, or present a ...

The Traditional 510(k) is used for any original device that has not been previously cleared and is not required to go through the PMA process. The Traditional 510(k) is also used for a change to a previously cleared device that does not qualify for a Special 510(k).

To submit your 510 K file, you need to create an account for your company. After login, you can pay the required 510 K application fee and submit your file to FDA's Center for Devices and Radiological Health (CDRH). Since December 2019 only one eCopy is required by FDA.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232