The following data is part of a premarket notification filed by Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. with the FDA for Flosteril Poly-reinforced Isolation Gowns Model 8120 (catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (catalogue Number 8120430), Flosteril Poly-re.
| Device ID | K210148 |
| 510k Number | K210148 |
| Device Name: | Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-re |
| Classification | Gown, Isolation, Surgical |
| Applicant | Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. Beysan Sanayi Sitesi, Dereboyu Caddesi. No 26 Kat: 3 Beylikduzu Istanbul, TR 34524 |
| Contact | Alaattin Saz |
| Correspondent | Jay Mansour Mansour Consulting LLC 845 Aronson Lake Court Roswell, GA 30075 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-21 |
| Decision Date | 2022-04-13 |