Device Classification Name |
Apparatus, Traction, Non-Powered
|
510(k) Number |
K860037 |
Device Name |
SUSPENDER ORTHOPEDIC SUSPENSION DEVICE |
Applicant |
COMFORTEX, INC. |
420 MAIN ST. |
WINONA,
MN
55987
|
|
Applicant Contact |
DONALD M SALYARDS |
Correspondent |
COMFORTEX, INC. |
420 MAIN ST. |
WINONA,
MN
55987
|
|
Correspondent Contact |
DONALD M SALYARDS |
Regulation Number | 888.5850
|
Classification Product Code |
|
Date Received | 01/06/1986 |
Decision Date | 01/21/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|