K-number	K922507
Device name	GERSON ISOLAIR APR PARTICULATE SURGICAL MASK
Applicant	Louis M. Gerson Co., Inc.
Product code	FXX
Device class	Class II
Decision date	Nov 16, 1992
Decision	Substantially Equivalent
Regulation	878.4040

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View the full FDA submission: accessdata.fda.gov

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GERSON ISOLAIR APR PARTICULATE SURGICAL MASK

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