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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K900350
Device Name LEOCOR CORFLO(TM) PUMP
Applicant
Leocor, Inc.
355 E. Nasa Rd.1
Webster,  TX  77598
Applicant Contact SNYDER, PHD
Correspondent
Leocor, Inc.
355 E. Nasa Rd.1
Webster,  TX  77598
Correspondent Contact SNYDER, PHD
Regulation Number870.2330
Classification Product Code
DXK  
Date Received01/24/1990
Decision Date 07/17/1990
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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