The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Spectra Blood Component Separator Therapeutic.
| Device ID | K900105 |
| 510k Number | K900105 |
| Device Name: | COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Moore, Jr. |
| Correspondent | Moore, Jr. COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| 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 | 1990-01-09 |
| Decision Date | 1991-03-22 |