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510(k) K851981

NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC. by Superior Plastic Products Corp. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1985
Date Received
May 7, 1985
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 Superior Plastic Products Corp.

  • K843975 — 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE (November 20, 1984)
  • K841945 — ENTERAL FEEDING BOTTLE (July 26, 1984)
  • K841630 — ENTERAL NUTRITION PUMP (June 7, 1984)
  • K840324 — SILICONE SUMP DRAIN 20 & 40 FRENCH (April 25, 1984)
  • K840323 — SILICONE SUCTION & IRRIGATION DRAIN (April 25, 1984)
  • K841480 — INFECTION CONTROL VALVE (April 25, 1984)
  • K833687 — DISPOS. ENTERIC FEEDING TUBES W/SAFE-T (March 2, 1984)
  • K833947 — SUPERIOR ENTERNAL FEEDING SYSTEM (February 4, 1984)
  • K820460 — 3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION (March 8, 1982)
  • K812312 — STERILE WATER 4OZ. (November 13, 1981)

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