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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 K183263
Device Name UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
Applicant
UNiPACK Medical Corporation
9830 Norwalk Blvd., Suite 100
Santa Fe Springs,  CA  90670
Applicant Contact Joe Pomparelli
Correspondent
UNiPACK Medical Corporation
9830 Norwalk Blvd., Suite 100
Santa Fe Springs,  CA  90670
Correspondent Contact Joe Pomparelli
Regulation Number878.4370
Classification Product Code
PEM  
Date Received11/23/2018
Decision Date 06/14/2019
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
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