Device Classification Name |
apparatus, traction, non-powered
|
510(k) Number |
K110858 |
Device Name |
LO-BAK TRAX |
Applicant |
ROLAND F BERTHIAUME, DC |
585 COOLEY STREET |
SPRINGFIELD,
MA
01128
|
|
Applicant Contact |
ROLAND F BERTHIAUME |
Correspondent |
ROLAND F BERTHIAUME, DC |
585 COOLEY STREET |
SPRINGFIELD,
MA
01128
|
|
Correspondent Contact |
ROLAND F BERTHIAUME |
Regulation Number | 888.5850
|
Classification Product Code |
|
Date Received | 03/28/2011 |
Decision Date | 08/02/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|