Device Classification Name |
dressing, wound and burn, hydrogel w/drug and/or biologic
|
510(k) Number |
K022995 |
Device Name |
COLLATEK HYDROGEL |
Applicant |
BIOCORE MEDICAL TECHNOLOGIES, INC. |
11800 TECH ROAD, |
SUITE # 240 |
SILVER SPRING,
MD
20904 -1908
|
|
Applicant Contact |
AJAY KUMAR |
Correspondent |
BIOCORE MEDICAL TECHNOLOGIES, INC. |
11800 TECH ROAD, |
SUITE # 240 |
SILVER SPRING,
MD
20904 -1908
|
|
Correspondent Contact |
AJAY KUMAR |
Classification Product Code |
|
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
|
|
|