The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Dental Membrane Iv.
| Device ID | K090216 |
| 510k Number | K090216 |
| Device Name: | COLLAGEN DENTAL MEMBRANE IV |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | COLLAGEN MATRIX, INC. 509 COMMERCE ST. Franklin Lakes, NJ 07417 |
| Contact | Peggy Hansen |
| Correspondent | Peggy Hansen 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 | 2009-01-29 |
| Decision Date | 2009-09-18 |
| Summary: | summary |