K-number	K192910
Device name	STATClave G4 Chamber Autoclave
Applicant	Scican , Ltd.
Product code	FLE
Device class	Class II
Decision date	Jun 19, 2020
Decision	Substantially Equivalent
Regulation	880.6880

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Source

View the full FDA submission: accessdata.fda.gov

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STATClave G4 Chamber Autoclave

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