Name: Predicase
Price: 199 USD

K-number	K070327
Device name	REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
Applicant	Sybron Dental Specialties, Inc.
Product code	LRK
Device class	Class II
Decision date	May 25, 2007
Decision	Substantially Equivalent
Regulation	872.5570

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Source

View the full FDA submission: accessdata.fda.gov

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REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR

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