CONSENSUS UNIPOLAR HEAD, COCR


Device Classification Name

prosthesis, hip, hemi-, femoral, metal

510(k) Number K030205
Device Name CONSENSUS UNIPOLAR HEAD, COCR
Original Applicant
HAYES MEDICAL, INC.
1115 windfield way, suite 100
el dorado hills, 
CA 
95762 -9623

Original Contact william j griffin
Regulation Number 888.3360
Classification Product Code
KWL  
Date Received 01/21/2003
Decision Date 04/01/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No