ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES


Device Classification Name

endoscopic tissue approximation device

510(k) Number K073644
Device Name ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES
Applicant
ENDOGASTRIC SOLUTIONS, INC.
8210 154th ave. ne
redmond, 
WA 
98052

Applicant Contact ken perino
Correspondent
ENDOGASTRIC SOLUTIONS, INC.
8210 154th ave. ne
redmond, 
WA 
98052

Correspodent Contact ken perino
Regulation Number 876.1500
Classification Product Code
OCW  
Date Received 12/26/2007
Decision Date 06/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No