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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 K040713
Device Name MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM
Applicant
Thomas Medical Products, Inc.
65 Great Valley Pkwy.
Malvern,  PA  19355
Applicant Contact TIM STOUDT
Correspondent
Thomas Medical Products, Inc.
65 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact TIM STOUDT
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/18/2004
Decision Date 06/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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