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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal
510(k) Number K833403
Device Name BDH UNIPOLAR FEMORAL COMPONENT A2
Applicant
Carbomedics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Carbomedics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3360
Classification Product Code
KWL  
Date Received09/30/1983
Decision Date 01/10/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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