K-number	K233132
Device name	PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
Applicant	Primus Sterilizer Company, LLC
Product code	FLE
Device class	Class II
Decision date	Dec 19, 2023
Decision	Substantially Equivalent
Regulation	880.6880

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View the full FDA submission: accessdata.fda.gov

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PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)

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