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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 K931194
Device Name CO-CR ANSWER FEMORAL COMPONENT
Applicant
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581
Applicant Contact DUTCH HARRISON
Correspondent
Biomet, Inc.
P.O. Box 587
Airport Industrial Park
Warsaw,  IN  46581
Correspondent Contact DUTCH HARRISON
Regulation Number888.3360
Classification Product Code
JDG  
Date Received03/09/1993
Decision Date 05/05/1994
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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