KERATEC WOUND DRESSINGS


Device Classification Name

dressing, wound, drug

510(k) Number K080949
Device Name KERATEC WOUND DRESSINGS
Applicant
KERATEC LIMITED
49 plain st.
north attleboro, 
MA 
02760

Applicant Contact mary mcnamara-cullinane
Correspondent
KERATEC LIMITED
49 plain st.
north attleboro, 
MA 
02760

Correspodent Contact mary mcnamara-cullinane
Classification Product Code
FRO  
Date Received 04/03/2008
Decision Date 02/11/2009
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes