The following data is part of a premarket notification filed by Ljungberg & Kogel with the FDA for Blood Mixing Device, Semi-automated.
Device ID | BK090010 |
510k Number | BK090010 |
Device Name: | Blood Mixing Device, Semi-automated |
Classification | Device, Mixing And Weighing, Semi-automated |
Applicant | Ljungberg & Kogel c/o Kamm & Associates 333 Milford Rd. Deerfield, IL 60015 US |
Product Code | MYJ |
CFR Regulation Number | 864.9195 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-02-27 |
Decision Date | 2009-07-17 |