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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Cement, For Clinical Use
510(k) Number K925025
Device Name PRISM BONE CEMENT MIXING SYSTEM
Applicant
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Applicant Contact ROBERT F SULLIVAN
Correspondent
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Correspondent Contact ROBERT F SULLIVAN
Regulation Number888.4210
Classification Product Code
JDZ  
Date Received10/02/1992
Decision Date 01/05/1994
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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