Name: Predicase
Price: 199 USD

K-number	K210414
Device name	CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
Applicant	Medtecs (Taiwan) Corp.
Product code	FYC
Device class	Class II
Decision date	Oct 21, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown

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