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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 K904041
Device Name HAEMONETICS CELL SAVER 4 PLUS
Applicant
Haemonetics Corp.
400 Wood Rd.
P.O. Box 9114
Braintree,  MA  02184
Applicant Contact MICHAEL MATHEWS
Correspondent
Haemonetics Corp.
400 Wood Rd.
P.O. Box 9114
Braintree,  MA  02184
Correspondent Contact MICHAEL MATHEWS
Regulation Number868.5830
Classification Product Code
CAC  
Date Received09/04/1990
Decision Date 11/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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