High Performance Antimicrobial Gelling Fiber With Silver

Dressing, Wound, Drug

Advanced Medical Solutions Ltd.

The following data is part of a premarket notification filed by Advanced Medical Solutions Ltd. with the FDA for High Performance Antimicrobial Gelling Fiber With Silver.

Pre-market Notification Details

Device IDK210974
510k NumberK210974
Device Name:High Performance Antimicrobial Gelling Fiber With Silver
ClassificationDressing, Wound, Drug
Applicant Advanced Medical Solutions Ltd. Premier Park, 33, Winsford Industrial Estate Winsford,  GB Cw7 3rt
ContactKay Mcgrath
CorrespondentKay Mcgrath
Advanced Medical Solutions Ltd. Premier Park, 33, Winsford Industrial Estate Winsford,  GB Cw7 3rt
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2021-04-01
Decision Date2021-05-12

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