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510(k) K791173

SURFLO INJECTION PLUG by Terumo America, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1979
Date Received
June 25, 1979
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 Terumo America, Inc.

  • K811523 — PLASMA FLEX (September 9, 1981)
  • K802970 — TERUMO HOLLOW FIBER OXYGENATOR (January 22, 1981)
  • K802441 — CLIRANS TH10 HOLLOW FIBER DIALYZER (December 18, 1980)
  • K802122 — CLIRANS TH13 HOLLOW FIBER DIALYZER (December 18, 1980)
  • K801193 — CLIRANS TE15 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K801192 — CLIRANS TE10 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K801194 — CLIRANS TE07 HOLLOW FIBER DIALYZER (August 12, 1980)
  • K791411 — COAXIAL DUAL FLOW CATHETER (November 13, 1979)
  • K790105 — TERUMO IMUGARD (May 24, 1979)
  • K772362 — AVF SET FOR SINGLE NEEDLE HEMODIALYSIS (March 17, 1978)

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