The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Flexible Cooagen Nerve Cuff.
| Device ID | K131541 |
| 510k Number | K131541 |
| Device Name: | FLEXIBLE COOAGEN NERVE CUFF |
| Classification | Cuff, Nerve |
| Applicant | COLLAGEN MATRIX, INC. 15 THORNTON ROAD Oakland, NJ 07436 |
| Contact | Peggy Hansen |
| Correspondent | Peggy Hansen COLLAGEN MATRIX, INC. 15 THORNTON ROAD Oakland, NJ 07436 |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-29 |
| Decision Date | 2014-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813954020112 | K131541 | 000 |
| 00813954020105 | K131541 | 000 |
| 00813954020099 | K131541 | 000 |
| 00813954020082 | K131541 | 000 |
| 00813954020075 | K131541 | 000 |
| 00813954020068 | K131541 | 000 |