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FDA 510(k) Application Details - DEN990005
Device Classification Name
System,Electrogastrography(Egg)
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
DANIEL J MANELLI
Other 510(k) Applications for this Contact
Regulation Number
876.1735
More FDA Info for this Regulation Number
Classification Product Code
MYE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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