HYALURONIC ACID TOPICAL WOUND CREAM

Dressing, Wound, Drug

VIRCHOW BIOTECH PVT LTD

The following data is part of a premarket notification filed by Virchow Biotech Pvt Ltd with the FDA for Hyaluronic Acid Topical Wound Cream.

Pre-market Notification Details

Device IDK172747
510k NumberK172747
Device Name:HYALURONIC ACID TOPICAL WOUND CREAM
ClassificationDressing, Wound, Drug
Applicant VIRCHOW BIOTECH PVT LTD 5903 SE Milwaukie Ave Portland,  OR  97202
ContactBruce Gibbins
CorrespondentBruce Gibbins
VIRCHOW BIOTECH PVT LTD 5903 SE Milwaukie Ave Portland,  OR  97202
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-12
Decision Date2018-04-27
Summary:summary

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