The following data is part of a premarket notification filed by Advanced Neuromodulation Systems with the FDA for Paindoc.
Device ID | K021518 |
510k Number | K021518 |
Device Name: | PAINDOC |
Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
Applicant | ADVANCED NEUROMODULATION SYSTEMS 6501 WINDCREST DRIVE SUITE 100 Plano, TX 75024 |
Contact | Rashmi Moza |
Correspondent | Rashmi Moza ADVANCED NEUROMODULATION SYSTEMS 6501 WINDCREST DRIVE SUITE 100 Plano, TX 75024 |
Product Code | GZB |
CFR Regulation Number | 882.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-10 |
Decision Date | 2002-06-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PAINDOC 74564195 2040994 Dead/Cancelled |
ADVANCED NEUROMODULATION SYSTEMS, INC. 1994-08-22 |