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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
510(k) Number K072125
Device Name ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT
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
ODE  
Date Received08/02/2007
Decision Date 10/18/2007
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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