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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 Device Evaluation (ODE)
Page __ of ___
(Posted November 13, 2003)
Back to the Indications for Use Page
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Center for Devices and Radiological Health / CDRH