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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
Model OVT-S27-160, OVT-027-160
Device Name OVERTUBE ENDOSCOPIC ACCESS SYSTEM
Applicant
APOLLO ENDOSURGERY, INC.
7000 bee caves rd. suite 350
austin,  TX  78746
Contact heather crawford, rac
Regulation Number876.1500
Classification Product Code
FED  
Date Received07/30/2012
Decision Date 09/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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