The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Dental Membrane.
| Device ID | K011695 |
| 510k Number | K011695 |
| Device Name: | COLLAGEN DENTAL MEMBRANE |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,, NJ 07417 |
| Contact | Shu-tung Li |
| Correspondent | Shu-tung Li COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,, NJ 07417 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-31 |
| Decision Date | 2001-08-07 |
| Summary: | summary |