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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 K043127
Device Name HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
Applicant
HAEMONETICS CORP.
400 WOOD RD.
P.O. BOX 9114
BRAINTREE,  MA  02184
Applicant Contact GABRIEL J MURACA
Correspondent
HAEMONETICS CORP.
400 WOOD RD.
P.O. BOX 9114
BRAINTREE,  MA  02184
Correspondent Contact GABRIEL J MURACA
Regulation Number868.5830
Classification Product Code
CAC  
Date Received11/12/2004
Decision Date 01/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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