The following data is part of a premarket notification filed by Jms Co., Ltd. with the FDA for Jms Av Fistula Needle.
| Device ID | K970962 |
| 510k Number | K970962 |
| Device Name: | JMS AV FISTULA NEEDLE |
| Classification | Needle, Fistula |
| Applicant | JMS CO., LTD. 12,17,KAKO-MACHI,NAKA-KU Hiroshima, 730, JP |
| Contact | T Hirose |
| Correspondent | T Hirose JMS CO., LTD. 12,17,KAKO-MACHI,NAKA-KU Hiroshima, 730, JP |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-17 |
| Decision Date | 1997-08-07 |