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FDA 510(k) Application Details - K092400
Device Classification Name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
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510(K) Number
K092400
Device Name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Applicant
ENDOGASTRIC SOLUTIONS, INC.
8210 154TH AVE. NE
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
08/06/2009
Decision Date
11/06/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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