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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 K110347
Device Name DOPPLER MONITOR
Applicant
Cook Vascular, Inc.
1186 Montgomery Lane
Vandergrift,  PA  15690
Applicant Contact JIM FERGUSON
Correspondent
Cook Vascular, Inc.
1186 Montgomery Lane
Vandergrift,  PA  15690
Correspondent Contact JIM FERGUSON
Regulation Number870.2100
Classification Product Code
DPW  
Subsequent Product Codes
ITX   JOP  
Date Received02/07/2011
Decision Date 03/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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