The following data is part of a premarket notification filed by Terumo Corporation with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.
Device ID | BK890017 |
510k Number | BK890017 |
Device Name: | Empty Containers For The Collection & Processing Of Blood/Blood Components |
Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
Applicant | Terumo Corporation 2805 East Ana Street Compton, CA 90221 |
Product Code | KSR |
CFR Regulation Number | 864.9100 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-15 |
Decision Date | 1990-07-18 |