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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 K071056
Device Name NEUTROPHASE WOUND CLEANSER
Applicant
Novabay Pharmaceuticals
5080 Horton St. Suite 550
Emeryville,  CA  94608
Applicant Contact LUANA STAIGER
Correspondent
Novabay Pharmaceuticals
5080 Horton St. Suite 550
Emeryville,  CA  94608
Correspondent Contact LUANA STAIGER
Classification Product Code
FRO  
Date Received04/16/2007
Decision Date 09/28/2007
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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