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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Restorative And Impression Material
510(k) Number K871937
Device Name IMPRESSION SYRINGE
Applicant
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Applicant Contact JOHN O SEMMELMAN
Correspondent
Dentsply Intl.
570 W. College Ave.
P.O. Box 872
York,  PA  17405
Correspondent Contact JOHN O SEMMELMAN
Regulation Number872.4565
Classification Product Code
EID  
Date Received05/18/1987
Decision Date 06/05/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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