LO-BAK TRAX


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

Correspodent Contact roland f berthiaume
Regulation Number 888.5850
Classification Product Code
HST  
Date Received 03/28/2011
Decision Date 08/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No