Name: Predicase
Price: 199 USD

K-number	K021076
Device name	PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM
Applicant	Primeline Medical Products, Inc.
Product code	FXX
Device class	Class II
Decision date	Apr 16, 2002
Decision	Substantially Equivalent
Regulation	878.4040

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View the full FDA submission: accessdata.fda.gov

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PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM

Everything you need for a 510(k) submission. Nothing you don't.