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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 K101907
Device Name HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
Applicant
Haemonetics Corp.
400 Wood Rd.
P.O. Box 9114
Braintree,  MA  02184
Applicant Contact GREG CALDER
Correspondent
Haemonetics Corp.
400 Wood Rd.
P.O. Box 9114
Braintree,  MA  02184
Correspondent Contact GREG CALDER
Regulation Number868.5830
Classification Product Code
CAC  
Date Received07/08/2010
Decision Date 12/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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