The following data is part of a premarket notification filed by Jms Co., Ltd. with the FDA for Vented I.v. Set.
| Device ID | K965027 |
| 510k Number | K965027 |
| Device Name: | VENTED I.V. SET |
| Classification | Set, Administration, Intravascular |
| Applicant | JMS CO., LTD. 12,17,KAKO-MACHI,NAKA-KU Hiroshima, 730, JP |
| Contact | Tetsukara Hirose |
| Correspondent | Tetsukara Hirose JMS CO., LTD. 12,17,KAKO-MACHI,NAKA-KU Hiroshima, 730, JP |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-17 |
| Decision Date | 1997-06-24 |