The following data is part of a premarket notification filed by Byron Medical with the FDA for Big Bag 3000 Pressure Infusor.
Device ID | K973133 |
510k Number | K973133 |
Device Name: | BIG BAG 3000 PRESSURE INFUSOR |
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 | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-21 |
Decision Date | 1997-09-12 |
Summary: | summary |