Medical Devices
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Indications for Use Form
510(k) Number (if known): ___________
Device Name: ________________________________________________
Indications for Use:
Prescription Use _______ (Part 21 CFR 801 Subpart D) |
AND/OR | Over-The-Counter Use _______ (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k)____________________
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