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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 K903026
Device Name ES-1000SP II SMART DOP
Applicant
Koven and Assoc., Inc.
The Trade Center
300 Brookes Dr., Suite 105
St. Louis,  MO  63042
Applicant Contact PAUL G KOVEN
Correspondent
Koven and Assoc., Inc.
The Trade Center
300 Brookes Dr., Suite 105
St. Louis,  MO  63042
Correspondent Contact PAUL G KOVEN
Regulation Number870.2100
Classification Product Code
DPW  
Date Received07/10/1990
Decision Date 02/26/1991
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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