Name: Predicase
Price: 199 USD

K-number	K210148
Device name	Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)
Applicant	Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.
Product code	FYC
Device class	Class II
Decision date	Apr 13, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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