The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Neurovision Jjb System.
Device ID | K040543 |
510k Number | K040543 |
Device Name: | NUVASIVE NEUROVISION JJB SYSTEM |
Classification | Stimulator, Nerve |
Applicant | NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
Contact | Laetitia Bernard |
Correspondent | Laetitia Bernard NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
Product Code | ETN |
CFR Regulation Number | 874.1820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-02 |
Decision Date | 2004-04-01 |
Summary: | summary |