510(k) K902759

COBE CLOSED WOUND DRAINAGE KIT by Cobe Laboratories, Inc. — Product Code CAC

K902759 is an FDA 510(k) premarket notification submitted by Cobe Laboratories, Inc. for the device "COBE CLOSED WOUND DRAINAGE KIT". The FDA issued a decision of Substantially Equivalent on July 18, 1990. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Cobe Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1990
Date Received
June 25, 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