The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for Blood Bank Supplies.
Device ID | BK900022 |
510k Number | BK900022 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | Haemonetics Corporation 400 Wood Road Braintree, MA 02184 |
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 | 1990-07-09 |
Decision Date | 1990-10-11 |