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510(k) K790967

CATHETER METAL HUB/RADIOPAQUE by Jelco Laboratories — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1979
Date Received
May 22, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Jelco Laboratories

  • K791918 — JELCO WINGED INTRAVASCULAR CATHETER (October 2, 1979)
  • K791372 — JELCO & KVO CATHETER PLACEMENT UNIT (September 12, 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)
  • K790107 — CATHETER TUBING MODIFICATION (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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