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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 K131542
Device Name NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC
Applicant
Novabay Pharmaceuticals, Inc.
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Applicant Contact PATSY J TRISLER
Correspondent
Novabay Pharmaceuticals, Inc.
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Correspondent Contact PATSY J TRISLER
Classification Product Code
FRO  
Date Received05/29/2013
Decision Date 07/24/2013
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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