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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 K220081
Device Name CORE-SPORT
Applicant
Incore Co., Ltd.
11, Hyeoksin-daero, 78-gil, Dong-gu
Daegu,  KR 41072
Applicant Contact Lee Jae-Hun
Correspondent
Incore Co., Ltd.
11, Hyeoksin-daero, 78-gil, Dong-gu
Daegu,  KR 41072
Correspondent Contact Lee Jae-Hun
Regulation Number876.1500
Classification Product Code
OTJ  
Date Received01/10/2022
Decision Date 09/28/2022
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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