Device Classification Name |
barrier, animal source, intraoral
|
510(k) Number |
K011695 |
Device Name |
COLLAGEN DENTAL MEMBRANE |
Applicant |
COLLAGEN MATRIX, INC. |
509 COMMERCE ST. |
FRANKLIN LAKES,,
NJ
07417
|
|
Applicant Contact |
SHU-TUNG LI |
Correspondent |
COLLAGEN MATRIX, INC. |
509 COMMERCE ST. |
FRANKLIN LAKES,,
NJ
07417
|
|
Correspondent Contact |
SHU-TUNG LI |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 05/31/2001 |
Decision Date | 08/07/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|