IODOFLEX

Dressing, Wound, Drug

Smith & Nephew Medical Ltd.

The following data is part of a premarket notification filed by Smith & Nephew Medical Ltd. with the FDA for Iodoflex.

Pre-market Notification Details

Device IDK190756
510k NumberK190756
Device Name:IODOFLEX
ClassificationDressing, Wound, Drug
Applicant Smith & Nephew Medical Ltd. 10 I Hessle Road Hull East Riding Of Yorkshire,  GB Hu32bn
ContactMeenakshi Gupta
CorrespondentAna Castillo
Smith & Nephew Medical Ltd. 10 I Hessle Road Hull East Riding Of Yorkshire,  GB Hu32bn
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-03-25
Decision Date2019-12-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00040565122533 K190756 000
00040565122519 K190756 000

Trademark Results [IODOFLEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IODOFLEX
IODOFLEX
74455774 2034068 Live/Registered
TJ SMITH & NEPHEW LIMITED
1993-11-09

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