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FDA 510(k), K211399, Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation Gown
FDA 510(k), K211399, Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation Gown
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510(K) Number: K211399
Device Name: Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation Gown
Manufacturer: Barco Tekstil Sanayi ve Ticaret A.S.
Device Classification Name: Gown, Surgical
Regulation Number: 878.4040
Classification Product Code: FYA
Date Received: 05/05/2021
Decision Date: 07/22/2022
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Sterile & Non-Sterile Level 3 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Gown, Sterile & Non-Sterile Level 4 Surgical Isolation Gown
Manufacturer: Barco Tekstil Sanayi ve Ticaret A.S.
Device Classification Name: Gown, Surgical
Regulation Number: 878.4040
Classification Product Code: FYA
Date Received: 05/05/2021
Decision Date: 07/22/2022
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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