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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 K990441
Device Name INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300
Applicant
SANDHILL SCIENTIFIC, INC.
8955 SOUTH RIDGELINE BLVD.,
UNIT #500
HIGHLANDS RANCH,  CO  80126
Applicant Contact LINDA L DIEDERICH
Correspondent
SANDHILL SCIENTIFIC, INC.
8955 SOUTH RIDGELINE BLVD.,
UNIT #500
HIGHLANDS RANCH,  CO  80126
Correspondent Contact LINDA L DIEDERICH
Regulation Number876.1725
Classification Product Code
FFX  
Date Received02/11/1999
Decision Date 05/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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