The following data is part of a premarket notification filed by Pacific Device, Inc. with the FDA for Vitalmix Plus Empty I.v. Container.
| Device ID | K972464 |
| 510k Number | K972464 |
| Device Name: | VITALMIX PLUS EMPTY I.V. CONTAINER |
| Classification | Container, I.v. |
| Applicant | PACIFIC DEVICE, INC. 8572 SPECTRUM LN. San Diego, CA 92121 |
| Contact | Donald R Young |
| Correspondent | Donald R Young PACIFIC DEVICE, INC. 8572 SPECTRUM LN. San Diego, CA 92121 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-01 |
| Decision Date | 1997-11-05 |