The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Blood Bank Supplies.
Device ID | BK030022 |
510k Number | BK030022 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | Fresenius Medical Care North America 6675 185th Avenue Ne suite 100 Redmond, WA 98052 US |
Product Code | KSS |
CFR Regulation Number | 864.9050 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-14 |
Decision Date | 2003-07-11 |