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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K013376
Device Name QFLOW 500 PERFUSION MONITORING SYSTEM
Applicant
Hemedex Incorporated
7 Tiffany Trail
Hopkonton,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
Hemedex Incorporated
7 Tiffany Trail
Hopkonton,  MA  01748
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number870.2100
Classification Product Code
DPW  
Date Received10/11/2001
Decision Date 05/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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