The following data is part of a premarket notification filed by Polyganics Bv with the FDA for Neurolac Nerve Guide Models Ng01-15/03, Ng01-020/03, Ng01 025/03, Ng01-030/03.
| Device ID | K032115 |
| 510k Number | K032115 |
| Device Name: | NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 |
| Classification | Cuff, Nerve |
| Applicant | Polyganics BV L.J. ZIELSTRAWEG 1 Groningen, NL 9713-gx |
| Contact | Jan Bart Hak |
| Correspondent | Jan Bart Hak Polyganics BV L.J. ZIELSTRAWEG 1 Groningen, NL 9713-gx |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-09 |
| Decision Date | 2003-10-10 |
| Summary: | summary |