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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 K160705
Device Name Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
Applicant
Y. Jacobs Medical, Inc.
6f Sangkyung Bldg. 669 Seolleung-Ro
Gangnam-Gu
Seoul,  KR 135-830
Applicant Contact HUI JUN PARK
Correspondent
Empirical Testing
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith May
Regulation Number878.4840
Classification Product Code
NEW  
Date Received03/14/2016
Decision Date 11/23/2016
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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