K-number	K151123
Device name	Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film
Applicant	Pac-Dent International, Inc.
Product code	PEM
Device class	Class II
Decision date	Mar 3, 2016
Decision	Substantially Equivalent
Regulation	878.4370

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View the full FDA submission: accessdata.fda.gov

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Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film

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