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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 K233111
Device Name ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC
Applicant
Foshan United Medical Technologies, Ltd.
Southern Medical Devices Industrial Park
89 Taoyuan E. Rd., Shishan, Nanhai
Guangdong Province,  CN 528225
Applicant Contact Albert Rego
Correspondent
Foshan United Medical Technologies, Ltd.
Southern Medical Devices Industrial Park
89 Taoyuan E. Rd., Shishan, Nanhai
Guangdong Province,  CN 528225
Correspondent Contact Albert Rego
Classification Product Code
FRO  
Date Received09/27/2023
Decision Date 05/24/2024
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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