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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 cleaner, ultrasound
De Novo Number DEN040004
510(K) Number K032378
Device Name CELLERATION MIST THERAPY SYSTEM
Requester
celleration
6570 edenvale blvd.
eden prairie,  MN  55346
Contact david l bremseth
Regulation Number878.4410
Classification Product Code
NRB  
Date Received04/29/2004
Decision Date 06/25/2004
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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