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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, steel, monofilament and multifilament, sterile
510(k) Number K193209
Device Name Wego-Stainless Steel
Applicant
Foosin Medical Supplies Inc., Ltd.
No.20, Xingshan Road, Weihai Torch Hi-tech Science Park
Weihai,  CN 264210
Applicant Contact Zhipeng Yang
Correspondent
Med-Link Consulting Co., Ltd
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received11/21/2019
Decision Date 02/19/2020
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
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