The following data is part of a premarket notification filed by Disetronic Medical Systems with the FDA for Disetronic Multifuse Pump System.
Device ID | K954826 |
510k Number | K954826 |
Device Name: | DISETRONIC MULTIFUSE PUMP SYSTEM |
Classification | Pump, Infusion |
Applicant | DISETRONIC MEDICAL SYSTEMS 5201 EAST RIVER RD. SUITE 312 Minneapolis, MN 55421 -1014 |
Contact | Robert Cerza |
Correspondent | Robert Cerza DISETRONIC MEDICAL SYSTEMS 5201 EAST RIVER RD. SUITE 312 Minneapolis, MN 55421 -1014 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-20 |
Decision Date | 1996-05-24 |
Summary: | summary |