The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Dental Membrane Iii.
| Device ID | K062846 |
| 510k Number | K062846 |
| Device Name: | COLLAGEN DENTAL MEMBRANE III |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,, NJ 07417 |
| Contact | Peggy Hanson |
| Correspondent | Peggy Hanson COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes,, NJ 07417 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-22 |
| Decision Date | 2006-10-13 |
| Summary: | summary |