K-number	K011789
Device name	PROCEDURE MASKS: PM4-301 AND PM4-304
Applicant	Primeline Medical Products, Inc.
Product code	FXX
Device class	Class II
Decision date	Jun 22, 2001
Decision	Substantially Equivalent
Regulation	878.4040

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View the full FDA submission: accessdata.fda.gov

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PROCEDURE MASKS: PM4-301 AND PM4-304

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