Device Classification Name |
Wound Dressing With Animal-Derived Material(S)
|
510(k) Number |
K122502 |
Device Name |
BRIDGE EXTRACELLULAR COLLEGEN MATRIX |
Applicant |
HARBOR MEDTECH, INC. |
4 JENNER |
SUITE 190 |
IRVINE,
CA
92618
|
|
Applicant Contact |
JERRY MEZGER |
Correspondent |
HARBOR MEDTECH, INC. |
4 JENNER |
SUITE 190 |
IRVINE,
CA
92618
|
|
Correspondent Contact |
JERRY MEZGER |
Classification Product Code |
|
Date Received | 08/16/2012 |
Decision Date | 02/26/2013 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|