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510(k) K790107

CATHETER TUBING MODIFICATION by Jelco Laboratories — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1979
Date Received
January 16, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Jelco Laboratories

  • K791918 — JELCO WINGED INTRAVASCULAR CATHETER (October 2, 1979)
  • K791372 — JELCO & KVO CATHETER PLACEMENT UNIT (September 12, 1979)
  • K790967 — CATHETER METAL HUB/RADIOPAQUE (June 27, 1979)
  • K790968 — CATHETER METAL HUB/NONRADIOPAQUE (June 11, 1979)
  • K790471 — JELCO* DISC FILTER-0.2 MICRON (April 30, 1979)
  • K790186 — PROTECTIVSTABILIZER (February 26, 1979)
  • K790079 — NEEDLE, BLOOD COLLECTING (February 1, 1979)
  • K781857 — TRAY, ARTERIAL BLOOD GAS SAMPLING (December 11, 1978)
  • K780896 — NEEDLES, DESIGN CHANGE, IV CATHETERS (August 23, 1978)
  • K780519 — FILTER TUBE (May 9, 1978)

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