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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 K003580
Device Name UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
Applicant
UNISENSOR AG
13605 WEST 7TH AVE.
GOLDEN,  CO  80401 -4604
Applicant Contact ROBERT N CLARK
Correspondent
UNISENSOR AG
13605 WEST 7TH AVE.
GOLDEN,  CO  80401 -4604
Correspondent Contact ROBERT N CLARK
Regulation Number876.1725
Classification Product Code
FFX  
Date Received11/20/2000
Decision Date 07/31/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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