K-number	K193383
Device name	SnugKap
Applicant	Headstart, Ltd.
Product code	MVA
Device class	Class II
Decision date	Jun 7, 2021
Decision	Substantially Equivalent
Regulation	882.5970

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Source

View the full FDA submission: accessdata.fda.gov

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SnugKap

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