The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Nerve Wrap.
| Device ID | K060952 |
| 510k Number | K060952 |
| Device Name: | COLLAGEN NERVE WRAP |
| Classification | Cuff, Nerve |
| 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 | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-06 |
| Decision Date | 2006-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813954020174 | K060952 | 000 |
| 00813954020167 | K060952 | 000 |
| 00813954020150 | K060952 | 000 |
| 00813954020143 | K060952 | 000 |
| 00813954020136 | K060952 | 000 |
| 00813954020129 | K060952 | 000 |