The following data is part of a premarket notification filed by Harvest Technologies with the FDA for Blood Bank Supplies.
Device ID | BK000037 |
510k Number | BK000037 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | Harvest Technologies 40 Grissom Road Plymouth, MA 02360 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 | 2000-08-11 |
Decision Date | 2001-02-05 |