FDA 510(k) Application Details - K984444

Device Classification Name System, Gastrointestinal Motility (Electrical)

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510(K) Number K984444
Device Name System, Gastrointestinal Motility (Electrical)
Applicant SANDHILL SCIENTIFIC, INC.
8955 SOUTH RIDGELINE BLVD.,
UNIT #500
HIGHLANDS RANCH, CO 80126 US
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Contact LINDA L DIEDERICH
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Regulation Number 876.1725

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Classification Product Code FFX
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Date Received 12/14/1998
Decision Date 01/11/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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