Name: Predicase
Price: 199 USD

K-number	K220345
Device name	STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
Applicant	Plasmapp Co,., Ltd.
Product code	MLR
Device class	Class II
Decision date	Apr 14, 2023
Decision	Substantially Equivalent
Regulation	880.6860

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Source

View the full FDA submission: accessdata.fda.gov

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STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

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