MICROINFUSOR

System, Gastrointestinal Motility (electrical)

SANDHILL SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Sandhill Scientific, Inc. with the FDA for Microinfusor.

Pre-market Notification Details

Device IDK932306
510k NumberK932306
Device Name:MICROINFUSOR
ClassificationSystem, Gastrointestinal Motility (electrical)
Applicant SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton,  CO  80120 -4535
ContactJudy K Griffith
CorrespondentJudy K Griffith
SANDHILL SCIENTIFIC, INC. 1501-N WEST CAMPUS DR. Littleton,  CO  80120 -4535
Product CodeFFX  
CFR Regulation Number876.1725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-11
Decision Date1994-04-01

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