K-number	K091272
Device name	BESMED JET NEBULIZER BOTTLE SET
Applicant	Besmed Health Business Corp
Product code	CAF
Device class	Class II
Decision date	Nov 10, 2009
Decision	Substantially Equivalent
Regulation	868.5630

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Source

View the full FDA submission: accessdata.fda.gov

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BESMED JET NEBULIZER BOTTLE SET

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