LT Antibacterial Alginate With Silver Dressing

Dressing, Wound, Drug

Zhejiang Longterm Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Zhejiang Longterm Medical Technology Co., Ltd. with the FDA for Lt Antibacterial Alginate With Silver Dressing.

Pre-market Notification Details

Device IDK192478
510k NumberK192478
Device Name:LT Antibacterial Alginate With Silver Dressing
ClassificationDressing, Wound, Drug
Applicant Zhejiang Longterm Medical Technology Co., Ltd. No. 493 North Huancheng Road, Mogan Mountain National High- Tech District Deqing,  CN 313200
ContactClaudia Zsang
CorrespondentClaudia Zsang
Zhenjiang Longterm Medical Technology Co., Ltd. No. 493 North Huancheng Road, Morgan Mountain National High- Tech District Deqing,  CN 313200
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-09-10
Decision Date2020-06-17

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.