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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 K980946
Device Name MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP
Applicant
Dentsleeve Pty., Ltd.
56 A/B Glen Osmond Rd.
Parkside South Australia,  AU 5063
Applicant Contact MARCUS TIPPETT
Correspondent
Dentsleeve Pty., Ltd.
56 A/B Glen Osmond Rd.
Parkside South Australia,  AU 5063
Correspondent Contact MARCUS TIPPETT
Regulation Number876.1725
Classification Product Code
FFX  
Date Received03/13/1998
Decision Date 06/08/1998
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
Predetermined Change
Control Plan Authorized		 No
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