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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Catheter
510(k) Number K901281
Device Name THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER
Applicant
Val-Mark Medical, Inc.
115 W. Logan St.
West St. Paul,  MN  55118
Applicant Contact STEVEN V BUSH
Correspondent
Val-Mark Medical, Inc.
115 W. Logan St.
West St. Paul,  MN  55118
Correspondent Contact STEVEN V BUSH
Regulation Number870.1380
Classification Product Code
DRB  
Date Received03/19/1990
Decision Date 08/28/1991
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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