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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 respiratory accessory microbial reduction device.
De Novo Number DEN210037
Device Name SoClean 3+ Bacterial Reduction Device
Requester
soclean, inc.
12 vose farm road
peterborough,  NH  03458
Contact george peters
Regulation Number880.6993
Classification Product Code
QXQ  
Date Received09/15/2021
Decision Date 08/12/2024
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
Type Direct
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