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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K884159
Device Name SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT
Applicant
MALLINCKROOT, INC.
675 MCDONNELL BLVD.
P.O. BOX 5840
ST. LOUIS,  MO  63134
Applicant Contact ROBERT S LAKE
Correspondent
MALLINCKROOT, INC.
675 MCDONNELL BLVD.
P.O. BOX 5840
ST. LOUIS,  MO  63134
Correspondent Contact ROBERT S LAKE
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/04/1988
Decision Date 02/22/1989
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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