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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
Original Applicant
DERMAL LIFE LLC
2995 steven martin dr.
fairfax,  VA  22031
Original Contact diane horwitz, ph.d., rac
Classification Product Code
FRO  
Date Received08/24/2012
Decision Date 05/01/2013
Decision substantially equivalent (SE)
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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