The following data is part of a premarket notification filed by Set Medikal Sanayi Ve Ticaret Anonim Sirketi with the FDA for 1 Ml Sterile Hypodermic Syringe For Single Use. With/without Needle. Luer/luer-lock.
| Device ID | K210200 |
| 510k Number | K210200 |
| Device Name: | 1 Ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock |
| Classification | Syringe, Piston |
| Applicant | Set Medikal Sanayi Ve Ticaret Anonim Sirketi Osmangazi Mahallesi Maresal Fevzi Cakmak Caddesi No.18 Esenyurt Istanbul, TR 34522 |
| Contact | Mehice Ozturk |
| Correspondent | Mehmet Fatih Ormeci Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi Taspinar Mahallesi 2800. Caddesi A-2 Apt. No:6 B/49 Ankara, TR 06830 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-25 |
| Decision Date | 2021-05-14 |