ALGS6 Ag Alginate Wound Dressing

Dressing, Wound, Drug

Foshan United Medical Technologies, Ltd.

The following data is part of a premarket notification filed by Foshan United Medical Technologies, Ltd. with the FDA for Algs6 Ag Alginate Wound Dressing.

Pre-market Notification Details

Device IDK172570
510k NumberK172570
Device Name:ALGS6 Ag Alginate Wound Dressing
ClassificationDressing, Wound, Drug
Applicant Foshan United Medical Technologies, Ltd. 89 Taoyuan East Road, Shishan, Nanhai Foshan,  CN 528225
ContactUna Chen
CorrespondentAlbert Rego
Albert Rego, Ph.D. Inc. 27001 La Paz Road, Suite #314 Mission Viejo,  CA  92691
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2017-08-28
Decision Date2018-05-11
Summary:summary

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