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FDA 510(k) Application Details - K073644
Device Classification Name
Endoscopic Tissue Approximation Device
More FDA Info for this Device
510(K) Number
K073644
Device Name
Endoscopic Tissue Approximation Device
Applicant
ENDOGASTRIC SOLUTIONS, INC.
8210 154TH AVE. NE
REDMOND, WA 98052 US
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Contact
KEN PERINO
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Regulation Number
876.1500
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Classification Product Code
OCW
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More FDA Info for this Product Code
Date Received
12/26/2007
Decision Date
06/27/2008
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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