K-number	K222977
Device name	DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip
Applicant	Macromedics BV
Product code	IYE
Device class	Class II
Decision date	Feb 17, 2023
Decision	Substantially Equivalent
Regulation	892.5050

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View the full FDA submission: accessdata.fda.gov

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DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip

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DSPS-Prominent Masks; DSPS-Prominent Baseplate, MR; CouchStrip