F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE


Device Classification Name

component, traction, invasive

510(k) Number K072432
Device Name F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
Applicant
HAND BIOMECHANICS LAB, INC.
77 scripps dr., suite 104
sacramento, 
CA 
95825

Applicant Contact jeff woodhouse
Correspondent
HAND BIOMECHANICS LAB, INC.
77 scripps dr., suite 104
sacramento, 
CA 
95825

Correspodent Contact jeff woodhouse
Regulation Number 888.3040
Classification Product Code
JEC  
Date Received 08/29/2007
Decision Date 01/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No