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FDA 510(k) Application Details - K984444
Device Classification Name
System, Gastrointestinal Motility (Electrical)
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
876.1725
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Classification Product Code
FFX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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