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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 K181141
Device Name OverStitch Endoscopic Suturing System and Accessories
Applicant
Apollo Endosurgery
1120 S. Capital Of Texas Hwy., Suite 300
Austin,  TX  78746
Applicant Contact Maritza Ward
Correspondent
Apollo Endosurgery
1120 S. Capital Of Texas Hwy., Suite 300
Austin,  TX  78746
Correspondent Contact Maritza Ward
Regulation Number876.1500
Classification Product Code
OCW  
Date Received05/01/2018
Decision Date 06/27/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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