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Medical Devices

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Indications for Use Form

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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 In Vitro Diagnostic Devices (OIVD)

 

______________________________
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k)____________________

 

Page 1 of ___

 

    
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