The following data is part of a premarket notification filed by Medsep Corporation with the FDA for Blood Bank Supplies.
Device ID | BK940018 |
510k Number | BK940018 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | Medsep Corporation 2200 Northern Boulevard East Hills, NY 11548 |
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 | 1994-04-21 |
Decision Date | 1994-09-07 |