WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS


Device Classification Name

component, traction, invasive

510(k) Number K030519
Device Name WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
Applicant
HAND BIOMECHANICS LAB, INC.
77 scripps dr., suite 104
sacramento, 
CA 
95825

Applicant Contact timothy r stallings
Correspondent
HAND BIOMECHANICS LAB, INC.
77 scripps dr., suite 104
sacramento, 
CA 
95825

Correspodent Contact timothy r stallings
Regulation Number 888.3040
Classification Product Code
JEC  
Date Received 02/19/2003
Decision Date 06/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No