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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K891687
Device Name EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE
Applicant
Medtronic Blood Systems, Inc.
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Applicant Contact SHARON ROCKWELL
Correspondent
Medtronic Blood Systems, Inc.
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Correspondent Contact SHARON ROCKWELL
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received03/22/1989
Decision Date 05/31/1989
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
Recalls CDRH Recalls
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