The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Duramatrix Collagen Dura Substitute Membrane - Onlay And Suturable.
| Device ID | K061487 |
| 510k Number | K061487 |
| Device Name: | DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE |
| Classification | Dura Substitute |
| 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 | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-31 |
| Decision Date | 2006-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813954022567 | K061487 | 000 |
| 00813954020242 | K061487 | 000 |
| 00813954020259 | K061487 | 000 |
| 00813954020266 | K061487 | 000 |
| 00813954020273 | K061487 | 000 |
| 00813954020280 | K061487 | 000 |
| 00813954022512 | K061487 | 000 |
| 00813954022529 | K061487 | 000 |
| 00813954022536 | K061487 | 000 |
| 00813954022543 | K061487 | 000 |
| 00813954022550 | K061487 | 000 |
| 00813954020235 | K061487 | 000 |