ENDOGASTRIC 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 Stomaphyx Device And Accessories.

Pre-market Notification Details

Device IDK062875
510k NumberK062875
Device Name:ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES
ClassificationEndoscopic Tissue Approximation Device
Applicant ENDOGASTRIC SOLUTIONS, INC. 8210 154TH AVE. NE Redmond,  WA  98052
ContactSteven J Hoffman
CorrespondentSteven J Hoffman
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 Received2006-09-26
Decision Date2007-03-09
Summary:summary

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