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510(k) K994197

DISENTRONIC PENFINE INJECTION PEN NEEDLE by Disetronic Medical Systems — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1999
Date Received
December 13, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Disetronic Medical Systems

  • K100704 — ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVIC (May 14, 2010)
  • K070189 — ACCU-CHEK ULTRAFLEX INFUSION SET (February 21, 2007)
  • 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)

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