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.
| Device ID | K211399 |
| 510k 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 |
| Classification | Gown, Surgical |
| Applicant | Barco Tekstil Sanayi Ve Ticaret A.S. Muratbey Mahallesi Karatoprak Caddesi No. 17 Istanbul, TR TR 34540 |
| Contact | Emre Gomruk |
| Correspondent | Mehmet Fatih Örmeci MEDCER Uluslararasi Medikal Belgelendirme A.S. Taspinar Mah. 2800 Cad. A-2 Apt. No:6 B/49 Ankara, TR 06830 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-05 |
| Decision Date | 2022-07-22 |