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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
Applicant
COBE LABORATORIES, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Applicant Contact LYNETTE MAKOWSKI
Correspondent
COBE LABORATORIES, INC.
1185 OAK ST.
LAKEWOOD,  CO  80215
Correspondent Contact LYNETTE MAKOWSKI
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/29/1988
Decision Date 06/10/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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