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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 K120299
Model SRS03
Device Name SRS ENDOSCOPIC STAPLING SYSTEM
Original Applicant
MEDIGUS, LTD.
555 13th street, nw
columbia square
washington,  DC  20004
Original Contact jonathan s kahan
Regulation Number876.1500
Classification Product Code
ODE  
Date Received01/31/2012
Decision Date 05/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Clinical Trials NCT00734747
Reviewed by Third Party No
Expedited Review No
Combination Product No
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