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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name suture, absorbable, synthetic, polyglycolic acid
510(k) Number K173043
Device Name Holycon Synthetic Absorbable Sutures
Applicant
Nantong Holycon Medical Devices Co., Ltd.
No.66, Zhongyang Road, Economic Technology Department Area
Nantong,  CN 226009
Applicant Contact Feng Lu
Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.4493
Classification Product Code
GAM  
Date Received09/28/2017
Decision Date 12/14/2017
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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