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 ID: K181315
• 510k Number: K181315
• Device Name: Antimicrobial Gauze Sponge Dressing, Antimicrobial Super Sponge Dressing, Antimicrobial Non-woven Sponge Dressing
• Classification: Dressing, Wound, Drug
• Applicant: Winner Medical Co., Ltd Winner Industrial Park, No. 660 Bulong Road Longhua District Shenzhen, CN 518109
• Contact: Dan Wang
• Correspondent: Diana Hong; Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai, CN 200120
• Product Code: FRO
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2018-05-18
• Decision Date: 2019-02-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04052199500492	K181315	000
20665973028099	K181315	000
20850044458688	K181315	000
10850044458674	K181315	000