Name: Predicase
Price: 199 USD

K-number	K981744
Device name	COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER
Applicant	W. Keith Thornton, D.D.S.
Product code	BZD
Device class	Class II
Decision date	Oct 14, 1998
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER

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