Name: Predicase
Price: 199 USD

K-number	K092012
Device name	PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
Applicant	Primed Medical Products, Inc.
Product code	FXX
Device class	Class II
Decision date	Sep 25, 2009
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70

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