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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyamide
510(k) Number K212603
Device Name Non Absorbable Surgical Nylon Suture
Applicant
Shandong Haidike Medical Product Co., Ltd.
Tianfu Road, Dongcheng District, Shan County
Heze,  CN 274300
Applicant Contact Lili Xu
Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number878.5020
Classification Product Code
GAR  
Date Received08/17/2021
Decision Date 12/22/2021
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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