FDA 510(k) Application Details - K092342

Device Classification Name Gastrointestinal Motility System, Capsule

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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
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Regulation Number 000.0000

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Classification Product Code NYV
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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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