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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 K100948
Device Name HYPO CLENZ WOUND WASH MODEL 100 PPM
Applicant
Nevoa Life Sciences, LLC
4807 El Camino Ave.,
Suite C
Carmichael,  CA  95608
Applicant Contact S. DAVID PIPER, PE
Correspondent
Nevoa Life Sciences, LLC
4807 El Camino Ave.,
Suite C
Carmichael,  CA  95608
Correspondent Contact S. DAVID PIPER, PE
Classification Product Code
FRO  
Date Received04/06/2010
Decision Date 02/02/2011
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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