OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER

Dressing, Wound, Drug

OCULUS INNOVATIVE SCIENCES, INC.

The following data is part of a premarket notification filed by Oculus Innovative Sciences, Inc. with the FDA for Oculus Puracyn Antimicrobial Skin And Wound Cleanser.

Pre-market Notification Details

Device IDK090206
510k NumberK090206
Device Name:OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER
ClassificationDressing, Wound, Drug
Applicant OCULUS INNOVATIVE SCIENCES, INC. 1135 N. MC DOWELL BLVD Petaluma,  CA  94954
ContactAntoinette Douglas
CorrespondentAntoinette Douglas
OCULUS INNOVATIVE SCIENCES, INC. 1135 N. MC DOWELL BLVD Petaluma,  CA  94954
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2009-01-28
Decision Date2009-06-02
Summary:summary

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