Name: Predicase
Price: 199 USD

K-number	K202845
Device name	Bodygard SFS Surgical Gown Level 3
Applicant	Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi
Product code	FYA
Device class	Class II
Decision date	Feb 24, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Bodygard SFS Surgical Gown Level 3

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