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FDA 510(k) Application Details - K171307
Device Classification Name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
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510(K) Number
K171307
Device Name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Applicant
EndoGastric Solutions, Inc.
18109 NE 76th Street Suite 100
Redmond, WA 98052 US
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Contact
Steve Hoffman
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Regulation Number
876.1500
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Classification Product Code
ODE
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Date Received
05/03/2017
Decision Date
06/22/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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