K-number	K214120
Device name	GSS610N21 Series Steam Sterilizer
Applicant	Maquet GmbH
Product code	FLE
Device class	Class II
Decision date	May 18, 2022
Decision	Substantially Equivalent
Regulation	880.6880

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Source

View the full FDA submission: accessdata.fda.gov

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GSS610N21 Series Steam Sterilizer

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