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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name handpiece, air-powered, root canal irrigation
510(k) Number K140685
Device Name ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
Applicant
SYBRONENDO
1717 W.COLLINS AVENUE
ORANGE,  CA  92867
Applicant Contact COURTNEY CLARK
Correspondent
SYBRONENDO
1717 W.COLLINS AVENUE
ORANGE,  CA  92867
Correspondent Contact COURTNEY CLARK
Regulation Number872.4200
Classification Product Code
NYL  
Date Received03/18/2014
Decision Date 07/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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