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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 K852425
Device Name CELL SAVER SUCTION SYSTEM
Applicant
HAEMONETICS CORP.
400 WOOD RD.
P.O. BOX 9114
BRAINTREE,  MA  02184
Applicant Contact PAUL H PATRONE
Correspondent
HAEMONETICS CORP.
400 WOOD RD.
P.O. BOX 9114
BRAINTREE,  MA  02184
Correspondent Contact PAUL H PATRONE
Regulation Number868.5830
Classification Product Code
CAC  
Date Received06/07/1985
Decision Date 09/03/1985
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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