Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation Gown

Gown, Surgical

Barco Tekstil Sanayi Ve Ticaret A.S.

The following data is part of a premarket notification filed by Barco Tekstil Sanayi Ve Ticaret A.s. with the FDA for Sterile & Non-sterile Level 3 Surgical Gown, Sterile & Non-sterile Level 4 Surgical Gown, Sterile & Non-sterile Level 4 Surgical Isolation Gown.

Pre-market Notification Details

Device IDK211399
510k NumberK211399
Device Name:Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation Gown
ClassificationGown, Surgical
Applicant Barco Tekstil Sanayi Ve Ticaret A.S. Muratbey Mahallesi Karatoprak Caddesi No. 17 Istanbul,  TR TR 34540
ContactEmre Gomruk
CorrespondentMehmet Fatih Örmeci
MEDCER Uluslararasi Medikal Belgelendirme A.S. Taspinar Mah. 2800 Cad. A-2 Apt. No:6 B/49 Ankara,  TR 06830
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-05
Decision Date2022-07-22

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