Device Classification Name |
Wound Dressing With Animal-Derived Material(S)
|
510(k) Number |
K122115 |
Device Name |
COLLAGEN DENTAL WOUND DRESSINGS |
Applicant |
COLLAGEN MATRIX, INC. |
15 THORNTON ROAD |
OAKLAND,
NJ
07436
|
|
Applicant Contact |
PEGGY HANSEN |
Correspondent |
COLLAGEN MATRIX, INC. |
15 THORNTON ROAD |
OAKLAND,
NJ
07436
|
|
Correspondent Contact |
PEGGY HANSEN |
Classification Product Code |
|
Date Received | 07/17/2012 |
Decision Date | 11/01/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|