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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 K120730
Device Name LOUTREX TOPICAL CREAM
Applicant
Acella Pharmaceuticals, LLC
248 Latitude Lane
Suite 104
Lake Wiley,  SC  29710
Applicant Contact LARA NOAH
Correspondent
Acella Pharmaceuticals, LLC
248 Latitude Lane
Suite 104
Lake Wiley,  SC  29710
Correspondent Contact LARA NOAH
Classification Product Code
FRO  
Date Received03/09/2012
Decision Date 09/06/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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