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Sponsor: Subject Device; File No.: Well Brain International Ltd. GYMFORM 'fABSAROUND, Model: VDPGYCIND0016 5170(k) submission report (Via.), Chapters6 Ki130074 Chapter 6. 510(k), Summary 51 0(k) Summary.

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21 CFR Part 820 Subpart O—Statistical Techniques What it covers: 21 CFR Part 820 Subpart O covers statistical techniques. Compliant statistical techniques are intended to help manufacturers establish, control, and verify the “acceptability of process capability and product characteristics.”

§ 812.1 Scope. An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device.

eCFR :: 21 CFR Part 814 -- Premarket Approval of Medical Devices.

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration.

Subpart C - Buildings and Facilities § 211.46 - Ventilation, air filtration, air heating and cooling. § 211.48 - Plumbing. § 211.50 - Sewage and refuse. § 211.52 - Washing and toilet facilities.

Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in ance with the general investigational plan and protocols ...

Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.

(1) A sponsor shall immediately conduct an evaluation of any unanticipated adverse device effect. (2) A sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to subjects shall terminate all investigations or parts of investigations presenting that risk as soon as possible.

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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
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
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