FDA 510(k) Application Details - DEN990005

Device Classification Name System,Electrogastrography(Egg)

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510(K) Number DEN990005
Device Name System,Electrogastrography(Egg)
Applicant 3PM CO., INC.
2000 M STREET, N.W.
7TH FLOOR
WASHINGTON, DC 20036-3307 US
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Contact DANIEL J MANELLI
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Regulation Number 876.1735

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Classification Product Code MYE
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Date Received 07/12/1999
Decision Date 08/20/1999
Decision DENG -
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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