The following data is part of a premarket notification filed by Polyganics Bv with the FDA for Neurolac Nerve Guide.
| Device ID | K050573 |
| 510k Number | K050573 |
| Device Name: | NEUROLAC NERVE GUIDE |
| Classification | Cuff, Nerve |
| Applicant | Polyganics BV L.J. ZIELSTRAWEG 1 Groningen, NL 9713-gx |
| Contact | Jan Nieuwenhuis |
| Correspondent | Jan Nieuwenhuis 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 | 2005-03-07 |
| Decision Date | 2005-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717703990188 | K050573 | 000 |
| 08717703990171 | K050573 | 000 |
| 08717703990164 | K050573 | 000 |
| 08717703990157 | K050573 | 000 |
| 08717703990140 | K050573 | 000 |
| 08717703990133 | K050573 | 000 |