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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 K053000
Device Name HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)
Original Applicant
HAEMONETICS CORP.
400 wood road
braintree,  MA  02184 -9114
Original Contact gabriel j muraca
Regulation Number868.5830
Classification Product Code
CAC  
Date Received10/25/2005
Decision Date 11/21/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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