Microcyn Plus Skin And Wound Hydrogel

Dressing, Wound, Drug

OCULUS INNOVATIVE SCIENCES

The following data is part of a premarket notification filed by Oculus Innovative Sciences with the FDA for Microcyn Plus Skin And Wound Hydrogel.

Pre-market Notification Details

Device IDK153648
510k NumberK153648
Device Name:Microcyn Plus Skin And Wound Hydrogel
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 Received2015-12-21
Decision Date2016-04-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.