The following data is part of a premarket notification filed by Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi with the FDA for Bodygard Sfs Surgical Gown Level 3.
| Device ID | K202845 |
| 510k Number | K202845 |
| Device Name: | Bodygard SFS Surgical Gown Level 3 |
| Classification | Gown, Surgical |
| Applicant | Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi Eskisehir Industrial Zone 26 Th Street No 9 Eskisehir, TR 26100 |
| Contact | Ali Serdar Serteser |
| Correspondent | Darren Reeves DP Distribution & Consulting, LLC 12240 Hunting Horn Lane Rockville, VA 23146 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-25 |
| Decision Date | 2022-02-24 |