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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K073671
Device Name PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
Applicant
NDO SURGICAL, INC.
125 HIGH ST.,
SUITE 7
MANSFIELD,  MA  02048
Applicant Contact JOHN J VOZELLA
Correspondent
NDO SURGICAL, INC.
125 HIGH ST.,
SUITE 7
MANSFIELD,  MA  02048
Correspondent Contact JOHN J VOZELLA
Regulation Number876.1500
Classification Product Code
OCW  
Date Received12/27/2007
Decision Date 03/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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