The following data is part of a premarket notification filed by Jms Co., Ltd. with the FDA for Jms A.v. Fistula Needle Set Wing Eater, Model 14g-18g.
| Device ID | K010406 |
| 510k Number | K010406 |
| Device Name: | JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | JMS CO., LTD. 12-17, KAKO-MACHI, NAKA-KU Hiroshima, JP 730-8652 |
| Contact | Keisuke Uratomi |
| Correspondent | Keisuke Uratomi JMS CO., LTD. 12-17, KAKO-MACHI, NAKA-KU Hiroshima, JP 730-8652 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-12 |
| Decision Date | 2001-06-20 |