SILVER ANTIMICROBIAL WOUND GEL

Dressing, Wound, Drug

ADVANCED MEDICAL SOLUTIONS LIMITED

The following data is part of a premarket notification filed by Advanced Medical Solutions Limited with the FDA for Silver Antimicrobial Wound Gel.

Pre-market Notification Details

Device IDK110458
510k NumberK110458
Device Name:SILVER ANTIMICROBIAL WOUND GEL
ClassificationDressing, Wound, Drug
Applicant ADVANCED MEDICAL SOLUTIONS LIMITED PREMIER PARK, 33 ROAD ONE, WINSFORD INDUSTRIAL ESTATE Winsford Cheshire,  GB Cw7 3pd
ContactClaire Ryan
CorrespondentClaire Ryan
ADVANCED MEDICAL SOLUTIONS LIMITED PREMIER PARK, 33 ROAD ONE, WINSFORD INDUSTRIAL ESTATE Winsford Cheshire,  GB Cw7 3pd
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2011-02-17
Decision Date2011-03-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10610888002071 K110458 000
07332551950200 K110458 000
05032749040127 K110458 000
20612479269181 K110458 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.