Name: Predicase
Price: 199 USD

K-number	K070782
Device name	WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F
Applicant	Survivair Respirators, LLC
Product code	MSH
Device class	Class II
Decision date	Apr 11, 2007
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F

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