SONAFINE WOUND DRESSING


Device Classification Name

dressing, wound, drug

510(k) Number K110172
Device Name SONAFINE WOUND DRESSING
Applicant
STRATUS PHARMACEUTICAL
12379 sw 130th street
miami, 
FL 
33186

Applicant Contact alberto hoyo
Correspondent
STRATUS PHARMACEUTICAL
12379 sw 130th street
miami, 
FL 
33186

Correspodent Contact alberto hoyo
Classification Product Code
FRO  
Date Received 01/20/2011
Decision Date 08/19/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes