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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 K080412
Device Name ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)
Applicant
SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD.
FLEMINGTON CT
#155
LA MIRADA,  CA  90638
Applicant Contact BRANDON CHOI
Correspondent
SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD.
FLEMINGTON CT
#155
LA MIRADA,  CA  90638
Correspondent Contact BRANDON CHOI
Regulation Number878.4493
Classification Product Code
GAM  
Date Received02/15/2008
Decision Date 09/04/2008
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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