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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ligator, Hemorrhoidal
510(k) Number K172985
Device Name Ligation Device
Applicant
Leo Medical Co., Ltd.
2 Floor, 10 Bldg.
18 Huashan Rd.
Changzhou,  CN 213022
Applicant Contact Yunpeng Ma
Correspondent
Leo Medical Co., Ltd.
2 Floor, 10 Bldg.
18 Huashan Rd.
Changzhou,  CN 213022
Correspondent Contact Yunpeng Ma
Regulation Number876.4400
Classification Product Code
FHN  
Subsequent Product Code
MND  
Date Received09/27/2017
Decision Date 06/14/2018
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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