The following data is part of a premarket notification filed by Sung Shim Medicare Co., Ltd. with the FDA for Sungshim Sterile Single Use Insulin Syringe.
| Device ID | K152803 |
| 510k Number | K152803 |
| Device Name: | SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | SUNG SHIM MEDICARE CO., LTD. 190, MAESIL-RO SOJEONG-MYEON Sejong-si, KR 30002 |
| Contact | Kim Young Kwan |
| Correspondent | Peter Chung PLUS GLOBAL 300 ATWOOD Pittsburgh, PA 15213 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-28 |
| Decision Date | 2016-07-12 |
| Summary: | summary |