Sterile Level 3 Surgical Gown— 510(k) K211399

Substantially Equivalent

Barco Tekstil Sanayi VE Ticaret A.S.

FDA 510(k) clearance K211399 for Sterile Level 3 Surgical Gown, Substantially Equivalent on 2022-07-22. Applicant: Barco Tekstil Sanayi VE Ticaret A.S..

Clearance details

Applicant: Barco Tekstil Sanayi VE Ticaret A.S.
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2021-05-05
Decision date: 2022-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Istanbul, TR

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