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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K082114
Device Name ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00
Applicant
APOLLO ENDOSURGERY, INC.
7000 BEE CAVES RD. SUITE 350
AUSTIN,  TX  78746
Applicant Contact DENNIS MCWILLIAMS
Correspondent
APOLLO ENDOSURGERY, INC.
7000 BEE CAVES RD. SUITE 350
AUSTIN,  TX  78746
Correspondent Contact DENNIS MCWILLIAMS
Regulation Number876.4300
Classification Product Code
KNS  
Date Received07/28/2008
Decision Date 12/19/2008
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
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