FDA 510(k) Application Details - K102214

Device Classification Name System, Gastrointestinal Motility (Electrical)

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510(K) Number K102214
Device Name System, Gastrointestinal Motility (Electrical)
Applicant CROSPON, LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS, FL 34134 US
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Contact PAUL DRYDEN
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Regulation Number 876.1725

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Classification Product Code FFX
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Date Received 08/06/2010
Decision Date 12/16/2010
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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