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510(k) K832622

WINGED INFUSION SET by Top Surgical Manufacturers Co. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1983
Date Received
August 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Top Surgical Manufacturers Co.

  • K844343 — TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE (January 8, 1985)
  • K843415 — TOP HYPODERMIC SYRINGE LUER LOCK (December 7, 1984)
  • K843313 — TOP DISPOSABLE SPINAL NEEDLE (September 19, 1984)
  • K843414 — TOP HYPODERMIC SYRINGE PISTON (September 7, 1984)
  • K841119 — TOPS DISPOS. INFUSION SET/HEMODIALYSIS (April 20, 1984)
  • K841025 — TOP DISPOSABLE INFUSION SET (March 30, 1984)
  • K832624 — TOP VENULA I.V. CATHETER SET (November 21, 1983)
  • K832625 — TOP THREE WAY STOPCOCK (October 19, 1983)
  • K832621 — TOP DISPOSABLE PLASTIC SYRINGES (October 14, 1983)
  • K832623 — TOP DISPOS. INFUSION SET/HEMODIALY (October 14, 1983)

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