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Get Fda Form 3429

E DEVICE FOR A USE WHICH IS OF SUBSTANTIAL IMPORTANCE IN PREVENTING IMPAIRMENT OF HUMAN HEALTH ? YES NO 3. DOES THE DEVICE PRESENT A POTENTIAL UNREASONABLE RISK OF ILLNESS OR INJURY ? YES NO 4. IS THERE SUFFICIENT INFORMATION TO DETERMINE THAT GENERAL CONTROLS ARE SUFFICIENT TO PROVIDE REASONABLE ASSURANCE OF SAFETY AND EFFECTIVENESS ? YES NO YES NO 5. IS THERE SUFFICIENT INFORMATION TO ESTABLISH SPECIAL CONTROLS IN ADDITION TO GENERAL CONTROLS TO PROVIDE REASONABLE ASSURANCE OF SAFET.

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