The following data is part of a premarket notification filed by Shina Med Corporation with the FDA for Surefine Pen Needle.
| Device ID | K152877 |
| 510k Number | K152877 |
| Device Name: | SureFine Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHINA MED CORPORATION 455-30, BOGAEWONSAM-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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2016-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00786227130897 | K152877 | 000 |
| 08800052600591 | K152877 | 000 |
| 08800052600621 | K152877 | 000 |
| 08800052600652 | K152877 | 000 |
| 08800052600683 | K152877 | 000 |
| 08800052600713 | K152877 | 000 |
| 08800052600744 | K152877 | 000 |
| 00786227101057 | K152877 | 000 |
| 00786227101293 | K152877 | 000 |
| 00786227111599 | K152877 | 000 |
| 00786227121093 | K152877 | 000 |
| 00786227121291 | K152877 | 000 |
| 00786227121598 | K152877 | 000 |
| 00786227121796 | K152877 | 000 |
| 00786227130590 | K152877 | 000 |
| 00786227130255 | K152877 | 000 |