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510(k) K092172

EXEL I.V. EXTENSION SET by Exelint Intl. Co. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2010
Date Received
July 21, 2009
Clearance Type
Traditional
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 Exelint Intl. Co.

  • K052103 — EXEL SECURE TOUCH II SAFETY SYRINGE (October 19, 2005)
  • K031500 — EXCEL PRIMARY SOLUTION SET (July 25, 2003)
  • K011754 — EXEL SECURETOUCH PTP SYRINGE (January 22, 2003)
  • K020533 — EXEL VACULET BLOOD COLLECTION SET (December 2, 2002)
  • K022406 — EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET (September 30, 2002)
  • K011757 — EXEL COMFORTPOINT INSULIN PEN NEEDLE (January 23, 2002)
  • K012879 — EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE (January 17, 2002)
  • K013037 — EXCEL A.V FISUTAL NEEDLE SET (December 7, 2001)
  • K011405 — EXEL INJECTION PLUG WITH CAP (September 27, 2001)
  • K010404 — EXEL I.V. ADMINISTRATION SET (August 30, 2001)

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