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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K081853
Device Name OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
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 Number876.1500
Classification Product Code
OCW  
Subsequent Product Code
HCF  
Date Received06/30/2008
Decision Date 08/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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