The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Vectra Stim Models 200 And 400.
Device ID | K982321 |
510k Number | K982321 |
Device Name: | VECTRA STIM MODELS 200 AND 400 |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | CHATTANOOGA GROUP, INC. 4717 ADAMS RD. P.O. BOX 4287 Hixson, TN 37343 |
Contact | Cheryl G Dyer |
Correspondent | Cheryl G Dyer CHATTANOOGA GROUP, INC. 4717 ADAMS RD. P.O. BOX 4287 Hixson, TN 37343 |
Product Code | GZJ |
Subsequent Product Code | IPF |
Subsequent Product Code | LIH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-07-02 |
Decision Date | 1999-02-01 |