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510(k) K183263

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope by Unipack Medical Corporation — Product Code PEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2019
Date Received
November 23, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dental Barriers And Sleeves
Device Class
Class II
Regulation Number
878.4370
Review Panel
DE
Submission Type

Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.

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