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Dentsleeve Pty., Ltd.
Dentsleeve Pty., Ltd.
Medical device manufacturer in Golden, CO.
3
510(k) clearances
0
PMA approvals
0
recalls
Device types
FFX System, Gastrointestinal Motility…
2
KLA Monitor, Esophageal Motility, Anorectal…
1
510(k) clearances
510(k)
Device
Decision
K013154
Mark Ii/Mark III Manometric Perfusion Pump
FFX · Special
10/19/2001
SE
K983665
Manometric Assemblies
KLA · Traditional
05/17/1999
SE
K980946
Mark II CO2 Flush Manometric Perfusion Pump & Mark II Manometric Perfusion Pump
FFX · Traditional
06/08/1998
SE