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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector, Bubble, Cardiopulmonary Bypass
510(k) Number K861860
Device Name COBE ACCESSORY INTERFACE MODULE (AIM)
Applicant
Cobe Laboratories, Inc.
1185 Oak St.
Lakewood,  CO  80215
Applicant Contact VERA BUFFALOE
Correspondent
Cobe Laboratories, Inc.
1185 Oak St.
Lakewood,  CO  80215
Correspondent Contact VERA BUFFALOE
Regulation Number870.4205
Classification Product Code
KRL  
Date Received05/14/1986
Decision Date 07/18/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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