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510(k) K052221

AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP by Sorenson Medical, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2005
Date Received
August 15, 2005
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Sorenson Medical, Inc.

  • K033425 — AMBIT INTERMITTENT AMBULATORY INFUSION PUMP (November 6, 2003)
  • K033325 — AMBIT CONTINUOUS AMBULATORY INFUSION PUMP (November 6, 2003)
  • K002434 — PALM PUMP (August 23, 2000)
  • K001287 — EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 300 (June 9, 2000)
  • K991363 — 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA (May 13, 1999)

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