The following data is part of a premarket notification filed by Terumo Bct, Inc. with the FDA for Spectra Optia Apheresis System.
Device ID | K172590 |
510k Number | K172590 |
Device Name: | Spectra Optia Apheresis System |
Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
Applicant | Terumo BCT, Inc. 10811 W. Collins Avenue Lakewood, CO 80215 |
Contact | Nicholas Wong |
Correspondent | Nicholas Wong Terumo BCT, Inc. 10811 W. Collins Avenue Lakewood, CO 80215 -4415 |
Product Code | LKN |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-29 |
Decision Date | 2018-03-02 |
Summary: | summary |