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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, gastrointestinal motility (electrical)
510(k) Number K012232
Device Name INSIGHT, MODEL S980000
Applicant
SANDHILL SCIENTIFIC, INC.
4655 KIRKWOOD CT
BOULDER,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
SANDHILL SCIENTIFIC, INC.
4655 KIRKWOOD CT
BOULDER,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number876.1725
Classification Product Code
FFX  
Date Received07/16/2001
Decision Date 06/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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