The following data is part of a premarket notification filed by Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri with the FDA for Bodygard Sfs Surgical Gown Level 4.
| Device ID | K221139 |
| 510k Number | K221139 |
| Device Name: | Bodygard SFS Surgical Gown Level 4 |
| Classification | Gown, Surgical |
| Applicant | Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi Ve Tic A. S. Eskisehir Organize Sanayi Bolgesi 26, Cadde No. 9 Odunpazari, TR 26110 |
| 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 | 2022-04-19 |
| Decision Date | 2022-11-10 |