The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Medi-sis Syringe Infusion System.
| Device ID | K972173 |
| 510k Number | K972173 |
| Device Name: | MEDI-SIS SYRINGE INFUSION SYSTEM |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | I-FLOW CORP. 2532 WHITE RD. Irvine, CA 92714 |
| Contact | Robert J Bard |
| Correspondent | Robert J Bard I-FLOW CORP. 2532 WHITE RD. Irvine, CA 92714 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-09 |
| Decision Date | 1997-08-15 |
| Summary: | summary |