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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscopic Single Port Access Device
510(k) Number K152598
Device Name Endo Keeper
Applicant
Nelis
1005,201-Doug Bucheon Techno Parl Ssangyong3cha
Samjeong-Dong Ojeong-Gu
Bucheon,  KR 421-742
Applicant Contact SEO OU NAM
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact PETER CHUNG
Regulation Number876.1500
Classification Product Code
OTJ  
Date Received09/11/2015
Decision Date 03/17/2016
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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