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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K903925
Device Name ARIES MELDICAL MODEL 2100HC HANK CRANK
Applicant
Aries Medical, Inc.
12 Elizabeth Dr.
Chelmsford,  MA  01824
Applicant Contact JAMES MAYOL
Correspondent
Aries Medical, Inc.
12 Elizabeth Dr.
Chelmsford,  MA  01824
Correspondent Contact JAMES MAYOL
Regulation Number870.4360
Classification Product Code
KFM  
Date Received08/13/1990
Decision Date 12/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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