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 |