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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 K013154
Device Name MARK II/MARK III MANOMETRIC PERFUSION PUMP
Applicant
Dentsleeve Pty., Ltd.
13605 W. 7th Ave.
Golden,  CO  80401
Applicant Contact ROBERT N CLARK
Correspondent
Dentsleeve Pty., Ltd.
13605 W. 7th Ave.
Golden,  CO  80401
Correspondent Contact ROBERT N CLARK
Regulation Number876.1725
Classification Product Code
FFX  
Date Received09/20/2001
Decision Date 10/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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