COLLATEK HYDROGEL


Device Classification Name

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

510(k) Number K022995
Device Name COLLATEK HYDROGEL
Original Applicant
BIOCORE MEDICAL TECHNOLOGIES, INC.
11800 tech road,
suite # 240
silver spring, 
MD 
20904 -1908

Original Contact ajay kumar
Classification Product Code
MGQ  
Date Received 09/09/2002
Decision Date 12/02/2002
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No