Name: Predicase
Price: 199 USD

K-number	K021546
Device name	DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
Applicant	Creative Contract (M) Sdn Bhd
Product code	FXX
Device class	Class II
Decision date	Mar 5, 2003
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR

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