Name: Predicase
Price: 199 USD

K-number	K081633
Device name	PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS
Applicant	Primed Medical Products, Inc.
Product code	FXX
Device class	Class II
Decision date	Aug 11, 2008
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS

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