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 |