FDA 510(k) Application Details - K942247

Device Classification Name System, Gastrointestinal Motility (Electrical)

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510(K) Number K942247
Device Name System, Gastrointestinal Motility (Electrical)
Applicant SANDHILL SCIENTIFIC, INC.
1501-N WEST CAMPUS DR.
LITTLETON, CO 80120-4535 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 05/09/1994
Decision Date 04/09/1996
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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