3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING

Dressing, Wound, Drug

3M COMPANY

The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Tegaderm Chg Chlorhexidine Gluconate I.v. Port Dressing.

Pre-market Notification Details

Device IDK123679
510k NumberK123679
Device Name:3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
ClassificationDressing, Wound, Drug
Applicant 3M COMPANY 3M CENTER, 2510 CONWAY AVE. BLDG. 275-5W-06 St. Paul,  MN  55144
ContactJoann Huehn
CorrespondentJoann Huehn
3M COMPANY 3M CENTER, 2510 CONWAY AVE. BLDG. 275-5W-06 St. Paul,  MN  55144
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2012-11-30
Decision Date2013-02-28
Summary:summary

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