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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K902953
Device Name SOFTOUCH GUIDING CATHETER
Applicant
Mallinckrodt Medical
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Applicant Contact DAVID E BROWN
Correspondent
Mallinckrodt Medical
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Correspondent Contact DAVID E BROWN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/05/1990
Decision Date 09/28/1990
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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