Name: Predicase
Price: 199 USD

K-number	K051583
Device name	TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050
Applicant	Tiara Medical Systems, Inc.
Product code	BZD
Device class	Class II
Decision date	Nov 4, 2005
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050

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