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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 K002427
Device Name SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
Applicant
Sandhill Scientific, Inc.
9150 Commerce Center Cir.
#500
Highlands Ranch,  CO  80129
Applicant Contact LIUNDA L DIEDERICH
Correspondent
Sandhill Scientific, Inc.
9150 Commerce Center Cir.
#500
Highlands Ranch,  CO  80129
Correspondent Contact LIUNDA L DIEDERICH
Regulation Number876.1725
Classification Product Code
FFX  
Date Received08/08/2000
Decision Date 06/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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