The following data is part of a premarket notification filed by Collagen Matrix, Inc. with the FDA for Reinforced Flexible Collagen Nerve Cuff.
| Device ID | K170656 |
| 510k Number | K170656 |
| Device Name: | Reinforced Flexible Collagen 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 | 2017-03-03 |
| Decision Date | 2017-06-01 |
| Summary: | summary |