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510(k) K861449

VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) by Exel Intl. — Product Code GIM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1986
Date Received
April 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vacuum Sample, With Anticoagulant
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
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)
  • K895772 — EXEL INDWELLING CATHETER (February 16, 1990)
  • K895769 — EXEL HUBER NEEDLE (February 16, 1990)
  • K895771 — EXEL SPINAL NEEDLES (February 16, 1990)

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  • K951886 — LOK-ON NEEDLE DISPOSAL SYSTEM (June 30, 1995)
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