CIDEX ACTIVATED DIALDEHYDE SOLUTION

Sterilant, Medical Devices

JOHNSON & JOHNSON CO.

The following data is part of a premarket notification filed by Johnson & Johnson Co. with the FDA for Cidex Activated Dialdehyde Solution.

Pre-market Notification Details

Device IDK060618
510k NumberK060618
Device Name:CIDEX ACTIVATED DIALDEHYDE SOLUTION
ClassificationSterilant, Medical Devices
Applicant JOHNSON & JOHNSON CO. 33 TECHNOLOGY DR Irvine,  CA  92618
ContactJoseph M Ascenzi
CorrespondentJoseph M Ascenzi
JOHNSON & JOHNSON CO. 33 TECHNOLOGY DR Irvine,  CA  92618
Product CodeMED  
CFR Regulation Number880.6885 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-08
Decision Date2006-04-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20705037044587 K060618 000

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