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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K172570
Device Name ALGS6 Ag Alginate Wound Dressing
Applicant
Foshan United Medical Technologies, Ltd.
89 Taoyuan E. Rd., Shishan, Nanhai
Foshan,  CN 528225
Applicant Contact Una Chen
Correspondent
Albert Rego, PhD, Inc.
27001 La Paz Rd.
Suite 314
Mission Viejo,  CA  92691
Correspondent Contact Albert Rego
Classification Product Code
FRO  
Date Received08/28/2017
Decision Date 05/11/2018
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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