Antimicrobial Gauze Sponge Dressing, Antimicrobial Super Sponge Dressing, Antimicrobial Non-woven Sponge Dressing

Dressing, Wound, Drug

Winner Medical Co., Ltd

The following data is part of a premarket notification filed by Winner Medical Co., Ltd with the FDA for Antimicrobial Gauze Sponge Dressing, Antimicrobial Super Sponge Dressing, Antimicrobial Non-woven Sponge Dressing.

Pre-market Notification Details

A PHP Error was encountered

Severity: Warning

Message: strpos(): Empty needle

Filename: fda.report/pmn_item.php

Line Number: 100

Backtrace:

File: /var/www/fda.report/pmn_item.php
Line: 100
Function: strpos

Device IDK181315
510k NumberK181315
Device Name:Antimicrobial Gauze Sponge Dressing, Antimicrobial Super Sponge Dressing, Antimicrobial Non-woven Sponge Dressing
ClassificationDressing, Wound, Drug
Applicant Winner Medical Co., Ltd Winner Industrial Park, No. 660 Bulong Road Longhua District Shenzhen,  CN 518109
ContactDan Wang
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai,  CN 200120
Product CodeFRO  
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2018-05-18
Decision Date2019-02-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04052199500492 K181315 000
20665973028099 K181315 000
20850044458688 K181315 000
10850044458674 K181315 000

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