The following data is part of a premarket notification filed by Gambro Bct, Inc. with the FDA for Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200.
Device ID | K071079 |
510k Number | K071079 |
Device Name: | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 |
Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
Applicant | GAMBRO BCT, INC. 10810 WEST COLLINS AVE. Lakewood, CO 80215 -4415 |
Contact | Patti L Arndt |
Correspondent | Patti L Arndt GAMBRO BCT, INC. 10810 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 | 2007-04-17 |
Decision Date | 2007-08-02 |
Summary: | summary |