3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE

Drape, Surgical

3M HEALTH CARE

The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Steri-drape Chg Antimicrobial Incise Drape.

Pre-market Notification Details

Device IDK140250
510k NumberK140250
Device Name:3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
ClassificationDrape, Surgical
Applicant 3M HEALTH CARE 3M CENTER, 2510 CONWAY AVE. BLDG 275-5W-06 St. Paul,  MN  55144
ContactKristin Totushek
CorrespondentKristin Totushek
3M HEALTH CARE 3M CENTER, 2510 CONWAY AVE. BLDG 275-5W-06 St. Paul,  MN  55144
Product CodeKKX  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-31
Decision Date2014-07-25
Summary:summary

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