The following data is part of a premarket notification filed by Sungshim Medicare Co., Ltd. with the FDA for Sungshim Insulin Pen Needle.
| Device ID | K152334 |
| 510k Number | K152334 |
| Device Name: | Sungshim Insulin Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SUNGSHIM MEDICARE CO., LTD. 190, MAESIL-RO, SOJEONG-MYEON Sejong-si, KR 30002 |
| Contact | Kim Young Kwan |
| Correspondent | Peter Chung PLUS GLOBAL 300 ATWOOD STREET Pittsburgh, PA 15213 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-19 |
| Decision Date | 2016-03-17 |
| Summary: | summary |