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510(k) K991203

IRRIGATION OR INFUSION PUMP K PUMP by Kmi Kolster Methods, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1999
Date Received
April 8, 1999
Clearance Type
Traditional
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 Kmi Kolster Methods, Inc.

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  • K012236 — STARS2000 POWER CANNULA (November 19, 2001)
  • K010702 — XUB EXTERNAL ULTRASOUND (August 9, 2001)
  • K002859 — SSW-STERILE SOLUTION WARMER (November 16, 2000)

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