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510(k) K813437

PAN SET by Sterile Design, Inc. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 8, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
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)
  • K842351 — STERILE DESIGN-CUSTOM STERILE IV KIT (October 15, 1984)
  • K834239 — SDI C-FLEX STERILE LIGHT HANDLE (April 25, 1984)
  • K834237 — GRADUATED GUIDE WIRE BOWL 8 (February 4, 1984)
  • K791738 — CUSTOM DRESSING CHANGE TRAYS (October 2, 1979)

Other clearances for product code FRG

  • K251347 — Sterilization Pouch/Roll (January 28, 2026)
  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
  • K241565 — Sterilization Package/Reel (February 24, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)