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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Esophageal Motility, Anorectal Motility, And Tube
510(k) Number K983665
Device Name MANOMETRIC ASSEMBLIES
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
KLA  
Date Received10/19/1998
Decision Date 05/17/1999
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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