The following data is part of a premarket notification filed by I-flow Corp. with the FDA for Paragon Infusion System With Bolus.
| Device ID | K023827 |
| 510k Number | K023827 |
| Device Name: | PARAGON INFUSION SYSTEM WITH BOLUS |
| Classification | Pump, Infusion |
| Applicant | I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
| Contact | Shane Noehre |
| Correspondent | Shane Noehre I-FLOW CORP. 20202 WINDROW DR. Lake Forest, CA 92630 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-18 |
| Decision Date | 2002-12-13 |
| Summary: | summary |