Name: Predicase
Price: 199 USD

K-number	K043382
Device name	TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840
Applicant	Tiara Medical Systems, Inc.
Product code	BZD
Device class	Class II
Decision date	Jan 19, 2005
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840

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