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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K201139
Device Name WEGO-PDO Barbed Suture
Applicant
Foosin Medical Supplies Inc., Ltd.
#20, Xingshan Rd., Weihai Torch Hi-Tech Science Park
Weihai,  CN 264210
Applicant Contact Zhipeng Yang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4840
Classification Product Code
NEW  
Date Received04/28/2020
Decision Date 10/20/2020
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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