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FDA 510(k) Application Details - K092342
Device Classification Name
Gastrointestinal Motility System, Capsule
More FDA Info for this Device
510(K) Number
K092342
Device Name
Gastrointestinal Motility System, Capsule
Applicant
THE SMARTPILL CORPORATION
847 MAIN ST.
BUFFALO, NY 14203-1109 US
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Contact
KATHLEEN SELOVER
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
NYV
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More FDA Info for this Product Code
Date Received
08/04/2009
Decision Date
10/30/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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