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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 system, electrogastrography (egg)
De Novo Number DEN990005
510(K) Number K984637
Device Name THE 3PM EGG MACHINE
Requester
3pm co., inc.
2000 m st., nw 7th floor
washington,  DC  20036
Contact daniel j manelli
Regulation Number876.1735
Classification Product Code
MYE  
Date Received07/12/1999
Decision Date 08/20/1999
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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