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510(k) K070189

ACCU-CHEK ULTRAFLEX INFUSION SET by Disetronic Medical Systems AG — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2007
Date Received
January 22, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Disetronic Medical Systems AG

  • K100704 — ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVIC (May 14, 2010)
  • K063146 — ACCU-CHEK LINKASSIST (November 27, 2006)
  • K060876 — ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACC (June 15, 2006)
  • K042887 — ACCU-CHEK SPIRIT (March 18, 2005)
  • K043000 — MODIFICATION TO D-TRONPLUS (December 1, 2004)
  • K033892 — ULTRAFLEX INFUSION SET (March 9, 2004)
  • K023471 — DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP (October 29, 2002)
  • K022831 — MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP (September 11, 2002)
  • K021725 — DISETRONIC D-TRON INSULIN INFUSION PUMP (August 2, 2002)
  • K013782 — DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE (November 20, 2001)

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