Device Classification Name |
equipment, traction, powered
|
510(k) Number |
K051938 |
Device Name |
TRITON/TRU-TRAC/TX TRACTION DEVICES |
Applicant |
CHATTANOOGA GROUP |
4717 ADAMS RD. |
P.O. BOX 489 |
HIXSON,
TN
37343
|
|
Applicant Contact |
CHERYL BAGWELL |
Correspondent |
CHATTANOOGA GROUP |
4717 ADAMS RD. |
P.O. BOX 489 |
HIXSON,
TN
37343
|
|
Correspondent Contact |
CHERYL BAGWELL |
Regulation Number | 890.5900
|
Classification Product Code |
|
Date Received | 07/18/2005 |
Decision Date | 09/21/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|