Name: Predicase
Price: 199 USD

K-number	K042267
Device name	INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP
Applicant	Inovel, LLC
Product code	MSH
Device class	Class II
Decision date	Sep 30, 2004
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP

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