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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 K112398
Device Name TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT
Applicant
GALT MEDICAL
5203 BRISTOL INDUSTRIAL WAY
BUFORD,  GA  30518
Applicant Contact BETSY CORTELLONI
Correspondent
GALT MEDICAL
5203 BRISTOL INDUSTRIAL WAY
BUFORD,  GA  30518
Correspondent Contact BETSY CORTELLONI
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/19/2011
Decision Date 04/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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