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510(k) K001287

EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML by Sorenson Medical, Inc. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2000
Date Received
April 24, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

Other clearances by Sorenson Medical, Inc.

  • K052221 — AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP (December 8, 2005)
  • K033425 — AMBIT INTERMITTENT AMBULATORY INFUSION PUMP (November 6, 2003)
  • K033325 — AMBIT CONTINUOUS AMBULATORY INFUSION PUMP (November 6, 2003)
  • K002434 — PALM PUMP (August 23, 2000)
  • K991363 — 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA (May 13, 1999)

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