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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Silk
510(k) Number K221767
Device Name Surgical Sutures with or without Needle
Applicant
Huaian Seamen Medical Technology Co., Ltd.
# 6, Wangyuan Pioneer Park (Qunli Rd.)
Yanhee St. Office
Huaian,  CN 223008
Applicant Contact Xinjie Zhang
Correspondent
Tianjin Zongxin Weiye Consulting Co, Ltd.
Bldg. 3, Jinfeng Bldg., Nankai District
Tianjin,  CN 300110
Correspondent Contact Liu Hui
Regulation Number878.5030
Classification Product Code
GAP  
Subsequent Product Codes
GAR   GAT   GAW  
Date Received06/17/2022
Decision Date 07/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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