The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Pain Doc.
Device ID | K941342 |
510k Number | K941342 |
Device Name: | PAIN DOC |
Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
Applicant | REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2010 Palm Harbor, FL 34682 |
Contact | Patrick J Lamb |
Correspondent | Patrick J Lamb REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2010 Palm Harbor, FL 34682 |
Product Code | GZB |
CFR Regulation Number | 882.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-22 |
Decision Date | 1995-10-13 |