The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Vivus 50 And Vivus 100 Personal Infuser.
| Device ID | K915646 |
| 510k Number | K915646 |
| Device Name: | VIVUS 50 AND VIVUS 100 PERSONAL INFUSER |
| Classification | Pump, Infusion |
| Applicant | I-FLOW CORP. 2532 WHITE RD. Irvine, CA 92714 |
| Contact | Robert Bard |
| Correspondent | Robert Bard I-FLOW CORP. 2532 WHITE RD. Irvine, CA 92714 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-18 |
| Decision Date | 1992-06-15 |