The following data is part of a premarket notification filed by Jeesung Medical Co Ltd with the FDA for Jsm Insulin Pen Needle.
| Device ID | K152166 |
| 510k Number | K152166 |
| Device Name: | JSM Insulin Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | JEESUNG MEDICAL CO LTD 54, MUJINI 1-GIL, DAEDEOK-GU Daejeon, KR |
| Contact | Choi Yong Hyun |
| 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 | 2015-08-04 |
| Decision Date | 2016-07-11 |
| Summary: | summary |