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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Thermodilution
510(k) Number K900710
Device Name INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
Applicant
Intec Medical, Inc.
1101 Resource Dr.
Suite 121
Plano,  TX  75074
Applicant Contact YELDERMAN, M.D.
Correspondent
Intec Medical, Inc.
1101 Resource Dr.
Suite 121
Plano,  TX  75074
Correspondent Contact YELDERMAN, M.D.
Regulation Number870.1915
Classification Product Code
KRB  
Date Received02/14/1990
Decision Date 10/19/1990
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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