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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, Femoral Component, Cemented, Metal
510(k) Number K792329
Device Name BIOPHASE IMPLANT MATERIAL
Applicant
Richard'S Medical Equip., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Richard'S Medical Equip., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3360
Classification Product Code
JDG  
Date Received11/19/1979
Decision Date 01/23/1980
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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