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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)
Applicant
HAEMONETICS CORP.
400 WOOD ROAD
BRAINTREE,  MA  02184 -9114
Applicant Contact GABRIEL J MURACA
Correspondent
HAEMONETICS CORP.
400 WOOD ROAD
BRAINTREE,  MA  02184 -9114
Correspondent 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 Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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