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510(k) K861153

DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES by Exel Intl. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1986
Date Received
March 26, 1986
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 Exel Intl.

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  • K963658 — EXEL AVF SINGLE NEEDLE (May 5, 1998)
  • 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)
  • K895768 — EXEL SAFELET CATHETER (February 16, 1990)

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