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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name wound dressing with poly(diallyl dimethyl ammonium chloride)(pdadmac)
De Novo Number DEN070002
510(K) Number K060662
Device Name QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
Requester
quick-med technologies, inc.
3427 sw 42nd way
gainesville,  FL  32608
Contact roy carr
Regulation Number878.4015
Classification Product Code
NYS  
Date Received05/10/2007
Decision Date 02/25/2009
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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