K-number	K940720
Device name	BUSSE ISOLATION AND PROCEDURAL MASKS
Applicant	Busse Hospital Disposables, Inc.
Product code	FXX
Device class	Class II
Decision date	Nov 2, 1994
Decision	Substantially Equivalent
Regulation	878.4040

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View the full FDA submission: accessdata.fda.gov

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BUSSE ISOLATION AND PROCEDURAL MASKS

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