The following data is part of a premarket notification filed by Polyganics Innovations Bv with the FDA for Nerve Capping Device.
| Device ID | K152684 |
| 510k Number | K152684 |
| Device Name: | Nerve Capping Device |
| Classification | Cuff, Nerve |
| Applicant | POLYGANICS INNOVATIONS BV ROZENBURGLAAN 15A Groningen, NL 9727 Dl |
| Contact | Betty Ijmker |
| Correspondent | Betty Ijmker POLYGANICS INNOVATIONS BV ROZENBURGLAAN 15A Groningen, NL 9727 Dl |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-18 |
| Decision Date | 2016-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717703990317 | K152684 | 000 |
| 08717703990300 | K152684 | 000 |
| 08717703990294 | K152684 | 000 |
| 08717703990287 | K152684 | 000 |
| 08717703990270 | K152684 | 000 |
| 08717703990263 | K152684 | 000 |
| 08717703990256 | K152684 | 000 |
| 08717703990249 | K152684 | 000 |
| 08717703990232 | K152684 | 000 |