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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 K944232
Device Name AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS
Applicant
HAEMONETICS CORP.
400 WOOD RD.
P.O. BOX 9114
BRAINTREE,  MA  02184
Applicant Contact MATTHEW NOWLAND
Correspondent
HAEMONETICS CORP.
400 WOOD RD.
P.O. BOX 9114
BRAINTREE,  MA  02184
Correspondent Contact MATTHEW NOWLAND
Regulation Number868.5830
Classification Product Code
CAC  
Date Received09/01/1994
Decision Date 07/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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