Device Classification Name |
Barrier, Animal Source, Intraoral
|
510(k) Number |
K110600 |
Device Name |
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN |
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 |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 03/02/2011 |
Decision Date | 07/29/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|