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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 K132329
Device Name NIVATOPIC PLUS
Applicant
Nivagen Pharmaceuticals, Inc.
248 Latitude Ln.
Suite 104
Lake Wiley,  SC  29710
Applicant Contact LARA NOAH
Correspondent
Nivagen Pharmaceuticals, Inc.
248 Latitude Ln.
Suite 104
Lake Wiley,  SC  29710
Correspondent Contact LARA NOAH
Classification Product Code
FRO  
Date Received07/26/2013
Decision Date 12/20/2013
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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