510(k) K213844
- Device
- Surgical Gown
- Applicant
- Bayteks Teknik Tekstil San. VE Tic. A.S.
- 510(k) number
- K213844
- Product code
- FYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-16
- Date received
- 2021-12-09
- Regulation
- 878.4040
- Classification name
- Gown, Surgical
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Spero Hegbe
- Address
- Organize Sanaji Bolgesi 19. Nolu Cad. # 9 Merkez TR 79000 79000
FDA Registration Numbers
- 3036773433
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Source Documents
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