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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 K201604
Device Name Plasdent Disposable Barrier Sleeves and Barrier Film
Applicant
Plasdent Corporation
969 Price St.
Pomona,  CA  91767
Applicant Contact Belen G Walayat
Correspondent
Plasdent Corporation
969 Price St.
Pomona,  CA  91767
Correspondent Contact Belen G Walayat
Regulation Number878.4370
Classification Product Code
PEM  
Date Received06/15/2020
Decision Date 12/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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