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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 K122431
Device Name HEARTSPAN STEERABLE INTRODUCER KIT
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 Received08/10/2012
Decision Date 01/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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