The following data is part of a premarket notification filed by Shina Med Corporation with the FDA for Sure-fine Insulin Syringes.
| Device ID | K191531 |
| 510k Number | K191531 |
| Device Name: | Sure-Fine Insulin Syringes |
| Classification | Syringe, Piston |
| Applicant | Shina Med Corporation 455-30 Bogaewonsam-ro, Bogae-myun Anseong-si, KR 456-871 |
| Contact | Park Sung-soon |
| Correspondent | Park Sung-soon Shina Med Corporation 455-30 Bogaewonsam-ro, Bogae-myun Anseong-si, KR 456-871 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-10 |
| Decision Date | 2019-09-06 |
| Summary: | summary |