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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dispenser, Cement
510(k) Number K897134
Device Name CMW CEMENT PRESSURISATION SYSTEM
Applicant
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Applicant Contact JEFFERY LEHN
Correspondent
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Correspondent Contact JEFFERY LEHN
Regulation Number888.4200
Classification Product Code
KIH  
Date Received12/27/1989
Decision Date 03/02/1990
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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