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510(k) K842356

CUSTOM STERILE PROCEDURE KITS by Sterile Design, Inc.

K842356 is an FDA 510(k) premarket notification submitted by Sterile Design, Inc. for the device "CUSTOM STERILE PROCEDURE KITS". The FDA issued a decision of Substantially Equivalent on March 21, 1985. Sterile Design, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1985
Date Received
June 15, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Sterile Design, Inc.

  • K934688 — STERILE DESIGN (March 16, 1994)
  • K841960 — CARDIO METRICS INVASIVE PRESSURE MONIT (November 8, 1985)
  • K841959 — CARDIO METRIC CUSTOM PERFUSION TUBING (October 19, 1984)
  • K842351 — STERILE DESIGN-CUSTOM STERILE IV KIT (October 15, 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)

FDA data resources