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U.S. Department of Health and Human Services

Medical Devices

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Indications for Use Form (Text Version)

Indications for Use

510(k) Number (if known): ___________

Device Name: ________________________________________________

Indications for Use:

 

 

 

 

 

 

 

 

 

 

 

 

Prescription Use _______
(Part 21 CFR 801 Subpart D)		AND/OROver-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)

 

 

 

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