HEALEX BIOSPONGE WOUND DRESSING


Device Classification Name

dressing, wound, drug

510(k) Number K112191
Device Name HEALEX BIOSPONGE WOUND DRESSING
Applicant
BIONOVA MEDICAL, INC
901 king st
suite 200
alexandria, 
VA 
22314

Applicant Contact deborah lavoie grayeski
Correspondent
BIONOVA MEDICAL, INC
901 king st
suite 200
alexandria, 
VA 
22314

Correspodent Contact deborah lavoie grayeski
Classification Product Code
FRO  
Date Received 07/29/2011
Decision Date 06/05/2012
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No