The following data is part of a premarket notification filed by Byron Medical with the FDA for Psi-tec Syringe Infusion Pump And Accessories For General Fluid Irrigaion/infiltration.
| Device ID | K980738 |
| 510k Number | K980738 |
| Device Name: | PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION |
| Classification | Pump, Infusion |
| Applicant | BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Contact | Steve Bollinger |
| Correspondent | Steve Bollinger BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-25 |
| Decision Date | 1998-06-16 |
| Summary: | summary |