The following data is part of a premarket notification filed by Polyganics Bv with the FDA for Neurolac(r) Nerve Guide.
| Device ID | K112267 |
| 510k Number | K112267 |
| Device Name: | NEUROLAC(R) NERVE GUIDE |
| Classification | Cuff, Nerve |
| Applicant | Polyganics BV ROZENBURGLAAN 15A Groningen, NL 9727-dl |
| Contact | Betty Ijmker |
| Correspondent | Betty Ijmker Polyganics BV ROZENBURGLAAN 15A Groningen, NL 9727-dl |
| Product Code | JXI |
| CFR Regulation Number | 882.5275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-08 |
| Decision Date | 2011-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717703990447 | K112267 | 000 |
| 08717703990430 | K112267 | 000 |
| 08717703990423 | K112267 | 000 |
| 08717703990416 | K112267 | 000 |