The following data is part of a premarket notification filed by Jms Co., Ltd. with the FDA for Jms Apheresis Needle.
| Device ID | K990510 |
| 510k Number | K990510 |
| Device Name: | JMS APHERESIS NEEDLE |
| Classification | Needle, Fistula |
| Applicant | JMS CO., LTD. 12-17, KAKO-MACHI, NAKA-KU Hiroshima, JP 730-8652 |
| Contact | Tetsuharu Hirose |
| Correspondent | Tetsuharu Hirose JMS CO., LTD. 12-17, KAKO-MACHI, NAKA-KU Hiroshima, JP 730-8652 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-18 |
| Decision Date | 1999-08-30 |