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510(k) K842351

STERILE DESIGN-CUSTOM STERILE IV KIT by Sterile Design, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1984
Date Received
June 15, 1984
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 Sterile Design, Inc.

  • K934688 — STERILE DESIGN (March 16, 1994)
  • K841960 — CARDIO METRICS INVASIVE PRESSURE MONIT (November 8, 1985)
  • K842356 — CUSTOM STERILE PROCEDURE KITS (March 21, 1985)
  • K841959 — CARDIO METRIC CUSTOM PERFUSION TUBING (October 19, 1984)
  • K841958 — CARDIO METRICS CARDIOTOMY RESERVOIR (October 15, 1984)
  • K834239 — SDI C-FLEX STERILE LIGHT HANDLE (April 25, 1984)
  • K834237 — GRADUATED GUIDE WIRE BOWL 8 (February 4, 1984)
  • K813437 — PAN SET (December 31, 1981)
  • K791738 — CUSTOM DRESSING CHANGE TRAYS (October 2, 1979)

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