3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad

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 Gel Pad.

Pre-market Notification Details

Device IDK200835
510k NumberK200835
Device Name:3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
ClassificationDressing, Wound, Drug
Applicant 3M Company Bldg. 275-5W-06 St. Paul,  MN  55144
ContactHilary B. Hovde
CorrespondentHilary B. Hovde
3M Company 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 Received2020-03-31
Decision Date2020-09-04

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