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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K122735
Model DTTS2
Device Name SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
Original Applicant
SORIN GROUP USA INC.
14401 west 65th way
arvada,  CO  80004
Original Contact scott light
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
GCJ  
Date Received09/06/2012
Decision Date 05/21/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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