Name: Predicase
Price: 199 USD

K-number	K132506
Device name	SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY
Applicant	Michael D Williams Dds PA
Product code	LRK
Device class	Class II
Decision date	May 29, 2014
Decision	Substantially Equivalent
Regulation	872.5570

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Source

View the full FDA submission: accessdata.fda.gov

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SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY

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