OPA 30 SOLUTION

Sterilant, Medical Devices

CIDEN TECHNOLOGIES LLC

The following data is part of a premarket notification filed by Ciden Technologies Llc with the FDA for Opa 30 Solution.

Pre-market Notification Details

Device IDK140703
510k NumberK140703
Device Name:OPA 30 SOLUTION
ClassificationSterilant, Medical Devices
Applicant CIDEN TECHNOLOGIES LLC 1717 W. COLLINS AVE. Orange,  CA  92867
ContactCourtney Clark
CorrespondentCourtney Clark
CIDEN TECHNOLOGIES LLC 1717 W. COLLINS AVE. Orange,  CA  92867
Product CodeMED  
CFR Regulation Number880.6885 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-20
Decision Date2014-08-19
Summary:summary

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