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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 K892937
Device Name REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS
Applicant
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Applicant Contact JOHN SEMMELMAN
Correspondent
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Correspondent Contact JOHN SEMMELMAN
Regulation Number888.4210
Classification Product Code
JDZ  
Date Received04/21/1989
Decision Date 06/22/1989
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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