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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 K920333
Device Name SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR
Applicant
Koven and Assoc., Inc.
The Trade Center
300 Brookes Dr., Suite 105
St. Louis,  MO  63042
Applicant Contact PAUL KOVEN
Correspondent
Koven and Assoc., Inc.
The Trade Center
300 Brookes Dr., Suite 105
St. Louis,  MO  63042
Correspondent Contact PAUL KOVEN
Regulation Number870.2100
Classification Product Code
DPW  
Date Received01/27/1992
Decision Date 01/22/1993
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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