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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 K894445
Device Name MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE
Applicant
Mallinckroot, Inc.
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Applicant Contact DAVID E BROWN
Correspondent
Mallinckroot, Inc.
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Correspondent Contact DAVID E BROWN
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/17/1989
Decision Date 10/02/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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