510(k) K902671

COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER by Cobe Laboratories, Inc. — Product Code CAC

K902671 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER". The FDA issued a decision of Substantially Equivalent on Jul 17, 1990. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Cobe Laboratories, Inc. has 76 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 17, 1990
Date Received
Jun 18, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Apparatus, Autotransfusion
Device Class
Class II
Regulation Number
868.5830
Review Panel
CV
Submission Type
510(k)

Source: FDA 510(k) database entry for K902671. Report a data issue: hello@regdatalab.com.