FDA 510(k) Application Details - K002427

Device Classification Name System, Gastrointestinal Motility (Electrical)

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510(K) Number K002427
Device Name System, Gastrointestinal Motility (Electrical)
Applicant SANDHILL SCIENTIFIC, INC.
9150 COMMERCE CENTER CIR.,#500
HIGHLANDS RANCH, CO 80129 US
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Contact LIUNDA L DIEDERICH
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Regulation Number 876.1725

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Classification Product Code FFX
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Date Received 08/08/2000
Decision Date 06/22/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review

FDA Source Information for K002427


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