K-number	K223738
Device name	Alpha Control Liner System (ACLS)
Applicant	Coapt
Product code	GXY
Device class	Class II
Decision date	Jan 11, 2023
Decision	Substantially Equivalent
Regulation	882.1320

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Source

View the full FDA submission: accessdata.fda.gov

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Alpha Control Liner System (ACLS)

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