The following data is part of a premarket notification filed by Chattanooga Group with the FDA for Triton/tru-trac/tx Traction Devices.
Device ID | K051938 |
510k Number | K051938 |
Device Name: | TRITON/TRU-TRAC/TX TRACTION DEVICES |
Classification | Equipment, Traction, Powered |
Applicant | CHATTANOOGA GROUP 4717 ADAMS RD. P.O. BOX 489 Hixson, TN 37343 |
Contact | Cheryl Bagwell |
Correspondent | Cheryl Bagwell CHATTANOOGA GROUP 4717 ADAMS RD. P.O. BOX 489 Hixson, TN 37343 |
Product Code | ITH |
CFR Regulation Number | 890.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-18 |
Decision Date | 2005-09-21 |