The following data is part of a premarket notification filed by Terumo Bct, Inc.. with the FDA for Spectra Optia Apheresis System, Spectra Optia System Software, Spectra Optia Exchange Disposable Set.
Device ID | K132429 |
510k Number | K132429 |
Device Name: | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET |
Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
Applicant | TERUMO BCT, INC.. 10811 WEST COLLINS AVE. Lakewood, CO 80215 -4415 |
Contact | Tina O'brien |
Correspondent | Tina O'brien TERUMO BCT, INC.. 10811 WEST COLLINS AVE. 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 | 2013-08-05 |
Decision Date | 2013-12-06 |
Summary: | summary |