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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 K123430
Model INT-101-XX, KIT-051-XX
Device Name MICROSLIDER TEARAWAY INTRODUCER SET
Original Applicant
GALT MEDICAL CORP.
2220 merritt dr.
garland,  TX  75041
Original Contact david derrick
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/14/2012
Decision Date 04/12/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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