The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Forte Es.
Device ID | K940759 |
510k Number | K940759 |
Device Name: | FORTE ES |
Classification | Stimulator, Neuromuscular, External Functional |
Applicant | CHATTANOOGA GROUP, INC. 4717 ADAMS RD. P.O. BOX 489 Hixson, TN 37343 -0489 |
Contact | Grahame R Watts |
Correspondent | Grahame R Watts CHATTANOOGA GROUP, INC. 4717 ADAMS RD. P.O. BOX 489 Hixson, TN 37343 -0489 |
Product Code | GZI |
CFR Regulation Number | 882.5810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-18 |
Decision Date | 1995-03-16 |