The following data is part of a premarket notification filed by Terumo Bct, Inc. with the FDA for Spectra Optia Apheresis System.
| Device ID | K181049 |
| 510k Number | K181049 |
| 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 |
| Product Code | LKN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-20 |
| Decision Date | 2018-11-01 |
| Summary: | summary |