The following data is part of a premarket notification filed by Shina Med Corporation with the FDA for Sure-fine Insulin Syringes.
| Device ID | K152879 |
| 510k Number | K152879 |
| Device Name: | Sure-Fine Insulin Syringes |
| Classification | Syringe, Piston |
| Applicant | SHINA MED CORPORATION 455-30, BOGAWONSAM-RO BOGAE-MYUN Anseong-si, KR 456-871 |
| Contact | Sung-soon Park |
| Correspondent | Priscilla Chung LK CONSULTING GROUP USA, INC. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2016-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00786227901091 | K152879 | 000 |
| 08800052600560 | K152879 | 000 |
| 08800052600522 | K152879 | 000 |
| 08800052600485 | K152879 | 000 |
| 08800052600447 | K152879 | 000 |
| 08800052600409 | K152879 | 000 |
| 08800052600362 | K152879 | 000 |
| 08800052600324 | K152879 | 000 |
| 08800052600287 | K152879 | 000 |
| 08800052600249 | K152879 | 000 |
| 08800052600201 | K152879 | 000 |
| 08800052600164 | K152879 | 000 |
| 08800052600126 | K152879 | 000 |
| 08800052600041 | K152879 | 000 |
| 00786227620398 | K152879 | 000 |
| 00786227620596 | K152879 | 000 |
| 00786227900599 | K152879 | 000 |
| 00786227900391 | K152879 | 000 |
| 00786227801094 | K152879 | 000 |
| 00786227800592 | K152879 | 000 |
| 00786227701097 | K152879 | 000 |
| 00786227700595 | K152879 | 000 |
| 00786227700359 | K152879 | 000 |
| 00786227651095 | K152879 | 000 |
| 00786227650593 | K152879 | 000 |
| 00786227650494 | K152879 | 000 |
| 00786227650395 | K152879 | 000 |
| 00786227621098 | K152879 | 000 |
| 08800052600089 | K152879 | 000 |