510(k) K900105
K900105 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC". The FDA issued a decision of Substantially Equivalent on Mar 22, 1991. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Cobe Laboratories, Inc. has 76 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 22, 1991
- Date Received
- Jan 9, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Separator, Automated, Blood Cell And Plasma, Therapeutic
- Device Class
- Class U
- Review Panel
- GU
- Submission Type
- 510(k)