Name: Predicase
Price: 199 USD

K-number	K053065
Device name	FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)
Applicant	Bryan Keropian Dds
Product code	LQZ
Device class	Class II
Decision date	Jan 3, 2006
Decision	Substantially Equivalent
Regulation	872.5570

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Source

View the full FDA submission: accessdata.fda.gov

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FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)

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