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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dental Barriers And Sleeves
510(k) Number K151123
FOIA Releasable 510(k) K151123
Device Name Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
Applicant
Pac-Dent International, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Applicant Contact Wenying Zhu
Correspondent
Pac-Dent International, Inc.
670 Endeavor Cir.
Brea,  CA  92821
Correspondent Contact Wenying Zhu
Regulation Number878.4370
Classification Product Code
PEM  
Date Received04/28/2015
Decision Date 03/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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