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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 K113820
Device Name NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER
Original Applicant
NOVABAY PHARMACEUTICALS
2081 longden circle
los altos,  CA  94024
Original Contact sheila w pickering
Classification Product Code
FRO  
Date Received12/27/2011
Decision Date 08/08/2012
Decision substantially equivalent (SESE)
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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