K-number	K190484
Device name	BH Medical Dental Barrier Sleeves and Barrier Film
Applicant	Bh Medical Products Co., Ltd.
Product code	PEM
Device class	Class II
Decision date	Sep 10, 2019
Decision	Substantially Equivalent
Regulation	878.4370

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Source

View the full FDA submission: accessdata.fda.gov

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BH Medical Dental Barrier Sleeves and Barrier Film

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