CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING


Device Classification Name

dressing, wound and burn, hydrogel w/drug and/or biologic

510(k) Number K022584
Device Name CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING
Original Applicant
CARDIOTECH INTL.
12106 west 75th ln.
arvada, 
CO 
80005 -5306

Original Contact andrew m reed
Classification Product Code
MGQ  
Date Received 08/05/2002
Decision Date 12/30/2002
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No