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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Grasping/Cutting Instrument, Non-Powered
510(k) Number K150939
Device Name Ensizor Endoscopic Scissors
Applicant
Slater Endoscopy, LLC
14000 NW 58th Court
Miami Lakes,  FL  33014
Applicant Contact JOHN STARKEY
Correspondent
C2c Development, LLC
1135 W Nasa Blvd., Suite 500
Melbourne,  FL  32901
Correspondent Contact CRAIG PAGAN
Regulation Number876.1500
Classification Product Code
OCZ  
Date Received04/07/2015
Decision Date 06/08/2015
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
Predetermined Change
Control Plan Authorized		 No
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