Home / 510(k) Clearances / K920339

510(k) K920339

DRESSING CHANGE TRAY by Medikmark, Inc. — Product Code FRG

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
April 23, 1992
Date Received
January 24, 1992
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 Medikmark, Inc.

  • K953474 — IV START KIT (October 2, 1995)
  • K923960 — UPPER EXTERMITY DRAPE KIT (October 7, 1994)
  • K921732 — MINOR LAP SET (June 15, 1994)
  • K921733 — TRACHEOSTOMY CARE TRAY (June 15, 1994)
  • K921730 — C-SECTION PACK (June 15, 1994)
  • K920340 — SUTURE REMOVAL KIT (April 23, 1992)
  • K920341 — LACERATION TRAYS (April 23, 1992)

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)