The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Neurovision Jjb System.
Device ID | K051718 |
510k Number | K051718 |
Device Name: | NUVASIVE NEUROVISION JJB SYSTEM |
Classification | Stimulator, Nerve |
Applicant | NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
Contact | Laetitia Cousin |
Correspondent | Laetitia Cousin NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
Product Code | ETN |
CFR Regulation Number | 874.1820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-27 |
Decision Date | 2005-09-15 |
Summary: | summary |