POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)


Device Classification Name

dressing, wound, drug

510(k) Number K121522
Device Name POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)
Applicant
POLYREMEDY, INC.
49 coastal oak
aliso viejo, 
CA 
92656

Applicant Contact gary mocnik
Correspondent
POLYREMEDY, INC.
49 coastal oak
aliso viejo, 
CA 
92656

Correspodent Contact gary mocnik
Classification Product Code
FRO  
Date Received 05/23/2012
Decision Date 06/27/2012
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes