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510(k) K963658

EXEL AVF SINGLE NEEDLE by Exel Intl. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1998
Date Received
September 3, 1996
Clearance Type
Traditional
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 Exel Intl.

  • K992290 — EXEL INJECTION PLUG WITH CAP (February 23, 2000)
  • K963659 — EXEL I.V. ADMINISTRATION SET (December 16, 1997)
  • K926119 — EXEL HUBER INFUSION SET ROTATING WING (August 11, 1993)
  • K904685 — EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) (November 21, 1990)
  • K903945 — EXEL A-V FISTULA SET (November 20, 1990)
  • K895770 — EXEL HUBER INFUSION SET (July 19, 1990)
  • K895771 — EXEL SPINAL NEEDLES (February 16, 1990)
  • K895772 — EXEL INDWELLING CATHETER (February 16, 1990)
  • K895769 — EXEL HUBER NEEDLE (February 16, 1990)
  • K895768 — EXEL SAFELET CATHETER (February 16, 1990)

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