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FDA 510(k) Application Details - K211399
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K211399
Device Name
Gown, Surgical
Applicant
Barco Tekstil Sanayi ve Ticaret A.S.
Muratbey Mahallesi Karatoprak Caddesi No. 17
Istanbul TR 34540 TR
Other 510(k) Applications for this Company
Contact
Emre Gomruk
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FYA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/05/2021
Decision Date
07/22/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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