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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 K120158
Device Name CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
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 Received01/18/2012
Decision Date 08/14/2012
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
Recalls CDRH Recalls
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