The following data is part of a premarket notification filed by Jms Co., Ltd. with the FDA for Jms Needles & Jms Syringes.
| Device ID | K845043 |
| 510k Number | K845043 |
| Device Name: | JMS NEEDLES & JMS SYRINGES |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | JMS CO., LTD. 12-17, KAKO-MACHI, NAKA-KU Hiroshima, JP 730-8652 |
| Contact | Iwao Yamasaki |
| Correspondent | Iwao Yamasaki JMS CO., LTD. 12-17, KAKO-MACHI, NAKA-KU Hiroshima, JP 730-8652 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-28 |
| Decision Date | 1985-04-29 |