Surgical Silver Post Operative Dressing

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 Surgical Silver Post Operative Dressing.

Pre-market Notification Details

Device IDK180634
510k NumberK180634
Device Name:Surgical Silver Post Operative Dressing
ClassificationDressing, Wound, Drug
Applicant Advanced Medical Solutions Ltd. Premier Park, 33 Road One, Winsford Industrial Estate Winsford,  GB Cw7 3rt
ContactRose Guang
CorrespondentRose Guang
Advanced Medical Solutions Ltd. Premier Park, 33 Road One, Winsford Industrial Estate Winsford,  GB Cw7 3rt
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2018-03-12
Decision Date2018-08-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888277717138 K180634 000
15032749025022 K180634 000
15032749025039 K180634 000
15032749025046 K180634 000
15032749025053 K180634 000
15032749025060 K180634 000
15032749027439 K180634 000
10193489020182 K180634 000
10888277717091 K180634 000
10888277717107 K180634 000
10888277717114 K180634 000
10888277717121 K180634 000
15032749025015 K180634 000

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