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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K881330
Device Name COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK
Original Applicant
COBE LABORATORIES, INC.
1185 oak st.
lakewood,  CO  80215
Original Contact lynette makowski
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/29/1988
Decision Date 06/10/1988
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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