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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 K121559
Device Name HYLATOPICPLUS LOTION
Original Applicant
PRECISION DERMATOLOGY INCORPORATED
900 highland corporate drive
cumberland,  RI  02864
Original Contact ronald m gurge
Classification Product Code
FRO  
Date Received05/29/2012
Decision Date 11/30/2012
Decision substantially equivalent (SE)
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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