NIVATOPIC PLUS

Dressing, Wound, Drug

NIVAGEN PHARMACEUTICALS INC.

The following data is part of a premarket notification filed by Nivagen Pharmaceuticals Inc. with the FDA for Nivatopic Plus.

Pre-market Notification Details

Device IDK132329
510k NumberK132329
Device Name:NIVATOPIC PLUS
ClassificationDressing, Wound, Drug
Applicant NIVAGEN PHARMACEUTICALS INC. 248 LATITUDE LANE, STE 104 Lake Wylie,  SC  29710
ContactLara Noah
CorrespondentLara Noah
NIVAGEN PHARMACEUTICALS INC. 248 LATITUDE LANE, STE 104 Lake Wylie,  SC  29710
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-26
Decision Date2013-12-20
Summary:summary

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