K-number	K212198
Device name	Tyvek(R) Roll with CI for STERLINKTM Sterilizer
Applicant	Plasmapp Co,., Ltd.
Product code	FRG
Device class	Class II
Decision date	Oct 22, 2021
Decision	Substantially Equivalent
Regulation	880.6850

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Source

View the full FDA submission: accessdata.fda.gov

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Tyvek(R) Roll with CI for STERLINKTM Sterilizer

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