The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Collagen Nerve Cuff.
| Device ID | K012814 |
| 510k Number | K012814 |
| Device Name: | COLLAGEN NERVE CUFF |
| Classification | Cuff, Nerve |
| 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 | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-22 |
| Decision Date | 2001-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813954020051 | K012814 | 000 |
| 00813954020044 | K012814 | 000 |
| 00813954020037 | K012814 | 000 |
| 00813954020020 | K012814 | 000 |
| 00813954020013 | K012814 | 000 |
| 00813954020006 | K012814 | 000 |