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510(k) K030576

ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II by The Anspach Effort, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2003
Date Received
February 24, 2003
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

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  • K113476 — ANSPACH DISSECTION TOOLS (December 16, 2011)
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  • K080802 — EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, E (April 30, 2008)
  • K061297 — ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (January 26, 2007)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)

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