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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic access overtube, gastroenterology-urology
510(k) Number K122270
Device Name OVERTUBE ENDOSCOPIC ACCESS SYSTEM
Applicant
APOLLO ENDOSURGERY, INC.
7000 BEE CAVES RD. SUITE 350
AUSTIN,  TX  78746
Applicant Contact HEATHER CRAWFORD, RAC
Correspondent
APOLLO ENDOSURGERY, INC.
7000 BEE CAVES RD. SUITE 350
AUSTIN,  TX  78746
Correspondent Contact HEATHER CRAWFORD, RAC
Regulation Number876.1500
Classification Product Code
FED  
Date Received07/30/2012
Decision Date 09/28/2012
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
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