HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM

Dressing, Wound, Drug

DERMAL LIFE LLC

The following data is part of a premarket notification filed by Dermal Life Llc with the FDA for Hydropermeate Topical Emulsion, Answer2skin Sunburn Relief Cream, Answer2skin First Aid Cream.

Pre-market Notification Details

Device IDK122595
510k NumberK122595
Device Name:HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM
ClassificationDressing, Wound, Drug
Applicant DERMAL LIFE LLC 2995 STEVEN MARTIN DR. Fairfax,  VA  22031
ContactDiane Horwitz, Ph.d., Rac
CorrespondentDiane Horwitz, Ph.d., Rac
DERMAL LIFE LLC 2995 STEVEN MARTIN DR. Fairfax,  VA  22031
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2012-08-24
Decision Date2013-05-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00369489522145 K122595 000
10369489522067 K122595 000

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