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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
Applicant
Precision Dermatology Incorporated
900 Highland Corporate Dr.
Cumberland,  RI  02864
Applicant Contact RONALD M GURGE
Correspondent
Precision Dermatology Incorporated
900 Highland Corporate Dr.
Cumberland,  RI  02864
Correspondent Contact RONALD M GURGE
Classification Product Code
FRO  
Date Received05/29/2012
Decision Date 11/30/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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