KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL

Mask, Surgical

KIMBERLY-CLARK

The following data is part of a premarket notification filed by Kimberly-clark with the FDA for Kc200, Surgical Mask, Kc200, Procedure Mask, Kc300, Surgicalmask, Fluidshield, Kc300, Procedure Mask, Fluidshield Model.

Pre-market Notification Details

Device IDK111402
510k NumberK111402
Device Name:KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL
ClassificationMask, Surgical
Applicant KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD Roswell,  GA  30076
ContactAnn Waterhouse, Rac
CorrespondentAnn Waterhouse, Rac
KIMBERLY-CLARK 1400 HOLCOMB BRIDGE ROAD Roswell,  GA  30076
Product CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-19
Decision Date2011-10-20
Summary:summary

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