The following data is part of a premarket notification filed by Biomet Biologics, Inc. with the FDA for Blood Bank Supplies.
Device ID | BK040036 |
510k Number | BK040036 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | Biomet Biologics, Inc. 56 East Bell Drive po Box 587 Warsaw, IN 46581 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 | 2004-04-22 |
Decision Date | 2004-06-18 |