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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
Device Name SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
Applicant
SORIN GROUP USA INC.
14401 WEST 65TH WAY
ARVADA,  CO  80004
Applicant Contact SCOTT LIGHT
Correspondent
SORIN GROUP USA INC.
14401 WEST 65TH WAY
ARVADA,  CO  80004
Correspondent 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 (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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