The following data is part of a premarket notification filed by Jung Rim Medical Industrial Co., Ltd with the FDA for Jung Rim Single Use Hypodermic Syringe With Needle.
| Device ID | K124037 |
| 510k Number | K124037 |
| Device Name: | JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE |
| Classification | Syringe, Piston |
| Applicant | JUNG RIM MEDICAL INDUSTRIAL CO., LTD #593-81, SAGOK-RI, LWOL-MYEON Jincheon-gun, Chungbuk, KP 365-820 |
| Contact | Kyu Lee |
| Correspondent | Kyu Lee JUNG RIM MEDICAL INDUSTRIAL CO., LTD #593-81, SAGOK-RI, LWOL-MYEON Jincheon-gun, Chungbuk, KP 365-820 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-28 |
| Decision Date | 2013-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00786227230078 | K124037 | 000 |
| 00786227053677 | K124037 | 000 |
| 00786227053578 | K124037 | 000 |
| 00786227053370 | K124037 | 000 |
| 00786227053271 | K124037 | 000 |
| 00786227053172 | K124037 | 000 |
| 00786227053073 | K124037 | 000 |
| 00786227046570 | K124037 | 000 |
| 00786227046075 | K124037 | 000 |
| 00786227043074 | K124037 | 000 |
| 00786227042077 | K124037 | 000 |
| 00786227041070 | K124037 | 000 |
| 00786227040578 | K124037 | 000 |
| 00786227040370 | K124037 | 000 |
| 00786227040172 | K124037 | 000 |
| 00786227016078 | K124037 | 000 |
| 00786227053776 | K124037 | 000 |
| 00786227053875 | K124037 | 000 |
| 00786227227078 | K124037 | 000 |
| 00786227225579 | K124037 | 000 |
| 00786227225173 | K124037 | 000 |
| 00786227225074 | K124037 | 000 |
| 00786227223179 | K124037 | 000 |
| 00786227223070 | K124037 | 000 |
| 00786227222172 | K124037 | 000 |
| 00786227222011 | K124037 | 000 |
| 00786227221571 | K124037 | 000 |
| 00786227221175 | K124037 | 000 |
| 00786227221076 | K124037 | 000 |
| 00786227220079 | K124037 | 000 |
| 00786227218175 | K124037 | 000 |
| 00786227218076 | K124037 | 000 |
| 00786227053974 | K124037 | 000 |
| 00786227010175 | K124037 | 000 |