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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 K031706
Device Name CARDIOQ, MODEL 9051-7005
Applicant
Deltex Medical
Terminus Rd.
Chichester, West Sussex,  GB PO19 8TX
Applicant Contact LAWERENCE BROOKFIELD
Correspondent
Deltex Medical
Terminus Rd.
Chichester, West Sussex,  GB PO19 8TX
Correspondent Contact LAWERENCE BROOKFIELD
Regulation Number870.2100
Classification Product Code
DPW  
Subsequent Product Codes
DPT   DSA  
Date Received06/02/2003
Decision Date 08/06/2003
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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