The following data is part of a premarket notification filed by Jms Co., Ltd. with the FDA for Modification Of Jms Needles And Jms Syringes.
| Device ID | K991904 |
| 510k Number | K991904 |
| Device Name: | MODIFICATION OF JMS NEEDLES AND JMS SYRINGES |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | JMS CO., LTD. 12,17,KAKO-MACHI,NAKA-KU Hiroshima, 730, JP |
| Contact | Keisuke Uratomi |
| Correspondent | Keisuke Uratomi JMS CO., LTD. 12,17,KAKO-MACHI,NAKA-KU Hiroshima, 730, JP |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-04 |
| Decision Date | 1999-08-31 |