KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100

Gown, Surgical

KIMBERLY-CLARK CORP.

The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimberly-clark Kc100 Surgical Gown, Model Kc100.

Pre-market Notification Details

Device IDK093115
510k NumberK093115
Device Name:KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100
ClassificationGown, Surgical
Applicant KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell,  GA  30076
ContactMarcia Johnson
CorrespondentMarcia Johnson
KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell,  GA  30076
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-02
Decision Date2010-03-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30680651792953 K093115 000
30680651117848 K093115 000
30680651133374 K093115 000
30680651451836 K093115 000
30680651451843 K093115 000
30680651992841 K093115 000
30680651992858 K093115 000
30680651792847 K093115 000
30680651792854 K093115 000
30680651792946 K093115 000
30680651117831 K093115 000

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