LOCOBASE WOUND AND SKIN EMULSION

Dressing, Wound, Drug

FERNDALE LABORATORIES, INC.

The following data is part of a premarket notification filed by Ferndale Laboratories, Inc. with the FDA for Locobase Wound And Skin Emulsion.

Pre-market Notification Details

Device IDK060272
510k NumberK060272
Device Name:LOCOBASE WOUND AND SKIN EMULSION
ClassificationDressing, Wound, Drug
Applicant FERNDALE LABORATORIES, INC. 780 WEST EIGHT MILE RD. Ferndale,  MI  48220
ContactRichard A Hamer
CorrespondentRichard A Hamer
FERNDALE LABORATORIES, INC. 780 WEST EIGHT MILE RD. Ferndale,  MI  48220
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2006-02-02
Decision Date2007-01-12
Summary:summary

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