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510(k) K080198

TSO3 OZONE STERILIZATION WRAP by Tso3, Inc. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2008
Date Received
January 25, 2008
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 Tso3, Inc.

  • K190260 — STERIZONE(R) VP4 Sterilizer (July 19, 2019)
  • K172191 — STERIZONE VP4 Sterilizer (May 9, 2018)
  • K173694 — STERIZONE VP4 Sterilizer (March 13, 2018)
  • K153689 — STERIZONE Sterilizer (June 30, 2016)
  • K141580 — STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR (December 17, 2014)
  • K141163 — STERIZONE STERILIZER (December 17, 2014)
  • K141698 — STERIZONE CHEMICAL INDICATOR (December 17, 2014)
  • K090636 — TSO3 OZONE STERILIZER, MODEL 125L (December 2, 2009)
  • K051595 — TSO3 OZONE STERILIZER, MODEL 125L (July 26, 2006)

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)