Name: Predicase
Price: 199 USD

K-number	K012207
Device name	ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530
Applicant	Tiara Medical Systems, Inc.
Product code	BZD
Device class	Class II
Decision date	Jul 23, 2001
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530

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