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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 K142810
Device Name WEGO-PGCL Absorbable Surgical Monofilament Suture
Applicant
FOOSIN MEDICAL SUPPLIES INC.LTD
No.20, Xingshan Road
Weihai Torch Hi-tech Science Park
WEIHAI,  CN 264210
Applicant Contact Suxia Zhao
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 Received09/29/2014
Decision Date 11/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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