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510(k) K980946

MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP by Dentsleeve Pty., Ltd. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1998
Date Received
March 13, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

Other clearances by Dentsleeve Pty., Ltd.

  • K013154 — MARK II/MARK III MANOMETRIC PERFUSION PUMP (October 19, 2001)
  • K983665 — MANOMETRIC ASSEMBLIES (May 17, 1999)

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