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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Autotransfusion
510(k) Number K902759
Device Name COBE CLOSED WOUND DRAINAGE KIT
Applicant
Cobe Laboratories, Inc.
14401 W. 56th Way
Arvada,  CO  80004
Applicant Contact MARY L ARMSTRONG
Correspondent
Cobe Laboratories, Inc.
14401 W. 56th Way
Arvada,  CO  80004
Correspondent Contact MARY L ARMSTRONG
Regulation Number868.5830
Classification Product Code
CAC  
Date Received06/25/1990
Decision Date 07/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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