Name: Predicase
Price: 199 USD

K-number	K202706
Device name	Surgical Gown (Sterile), Surgical Gown (Non-sterile)
Applicant	B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
Product code	FYA
Device class	Class II
Decision date	Dec 31, 2020
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Surgical Gown (Sterile), Surgical Gown (Non-sterile)

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