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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 device, engorgement, clitoral
De Novo Number DEN000006
510(K) Number K000280
Device Name EROS-CLITORAL THERAPY DEVICE (CTD)
Requester
urometrics, inc.
445 etna st., suite 56
st. paul,  MN  55106
Contact philip a messina
Regulation Number884.5970
Classification Product Code
NBV  
Date Received04/27/2000
Decision Date 04/28/2000
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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