ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES

Endoscopic Tissue Approximation Device

ENDOGASTRIC SOLUTIONS, INC.

The following data is part of a premarket notification filed by Endogastric Solutions, Inc. with the FDA for Endogastric Solutions Stomaphyx Device And Accessories.

Pre-market Notification Details

Device IDK073644
510k NumberK073644
Device Name:ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
ClassificationEndoscopic Tissue Approximation Device
Applicant ENDOGASTRIC SOLUTIONS, INC. 8210 154TH AVE. NE Redmond,  WA  98052
ContactKen Perino
CorrespondentKen Perino
ENDOGASTRIC SOLUTIONS, INC. 8210 154TH AVE. NE Redmond,  WA  98052
Product CodeOCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-26
Decision Date2008-06-27
Summary:summary

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