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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dressing, wound, drug
510(k) Number K122595
Device Name HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM
Applicant
DERMAL LIFE LLC
2995 STEVEN MARTIN DR.
FAIRFAX,  VA  22031
Applicant Contact DIANE HORWITZ, PH.D., RAC
Correspondent
Journey Medical Corporation
9237 Via De Ventura, Suite 105
Scottsdale,  AZ  85258
Correspondent Contact Claude Maraoui
Classification Product Code
FRO  
Date Received08/24/2012
Decision Date 05/01/2013
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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