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510(k) K982966

DISETRONIC PEN by Disetronic Medical Systems — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1998
Date Received
August 25, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Disetronic Medical Systems

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  • 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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