Name: Predicase
Price: 199 USD

K-number	K203606
Device name	Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
Applicant	Meris Investment Group
Product code	LRK
Device class	Class II
Decision date	Mar 10, 2021
Decision	Substantially Equivalent
Regulation	872.5570

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Source

View the full FDA submission: accessdata.fda.gov

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Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)

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