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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 K160761
Device Name DW-1C
Applicant
Dongwon Medical Co., Ltd.
201-Ho, 35, Saam-Ro 340beon-Gil
Gwangsan-Gu, Gwangju, Korea
Gwangju,  KR 62328
Applicant Contact Gil Haeng Lee
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number878.4840
Classification Product Code
NEW  
Date Received03/21/2016
Decision Date 11/22/2016
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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