Name: Predicase
Price: 199 USD

K-number	K060273
Device name	SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837
Applicant	Sleepnet Corporation
Product code	BZD
Device class	Class II
Decision date	May 2, 2006
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837

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