Alevicyn SG Antipruritic Gel

Dressing, Wound, Drug

OCULUS INNOVATIVE SCIENCES

The following data is part of a premarket notification filed by Oculus Innovative Sciences with the FDA for Alevicyn Sg Antipruritic Gel.

Pre-market Notification Details

Device IDK143590
510k NumberK143590
Device Name:Alevicyn SG Antipruritic Gel
ClassificationDressing, Wound, Drug
Applicant OCULUS INNOVATIVE SCIENCES 1129 N MCDOWELL BLVD Petaluma,  CA  94954
ContactBrian W Martin
CorrespondentBrian W Martin
OCULUS INNOVATIVE SCIENCES 1129 N MCDOWELL BLVD Petaluma,  CA  94954
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2014-12-18
Decision Date2015-06-04
Summary:summary

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