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)— 510(k) K210148

Substantially Equivalent

Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.

FDA 510(k) clearance K210148 for 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), Substantially Equivalent on 2022-04-13. Applicant: Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti..

Clearance details

Applicant: Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.
Product code: Code FYC
Advisory panel: General, Plastic Surgery
Date received: 2021-01-21
Decision date: 2022-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Istanbul, TR

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.