The following data is part of a premarket notification filed by Jms Co., Ltd. with the FDA for Jms Lcc Insulin Syringe.
| Device ID | K853838 |
| 510k Number | K853838 |
| Device Name: | JMS LCC INSULIN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | JMS CO., LTD. 12-17, KAKO-MACHI, NAKA-KU Hiroshima, JP 730-8652 |
| Contact | Pettit |
| Correspondent | Pettit JMS CO., LTD. 12-17, KAKO-MACHI, NAKA-KU Hiroshima, JP 730-8652 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-05 |
| Decision Date | 1985-10-16 |