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510(k) K941467

WOUND DRESSING KIT by Clinical Resources, Inc. — Product Code FRG

K941467 is an FDA 510(k) premarket notification submitted by Clinical Resources, Inc. for the device "WOUND DRESSING KIT". The FDA issued a decision of Substantially Equivalent on May 12, 1994. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Clinical Resources, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1994
Date Received
March 28, 1994
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 Clinical Resources, Inc.

  • K941470 — TRACHEOSTOMY CARE KIT (February 14, 1995)
  • K944882 — IRRIGATION TRAY (January 12, 1995)
  • K944881 — SKIN SCRUB TRAY (December 27, 1994)
  • K944879 — GAUZE SPONGES (December 23, 1994)
  • K945020 — FLUFF GAUZE SPONGE (December 23, 1994)
  • K945019 — FLUFF GAUXZE ROLL (December 23, 1994)
  • K945021 — FLUFF GAUZE SPONGE (December 23, 1994)
  • K944880 — BODILY FLUID DISPOSAL KIT (December 15, 1994)
  • K941471 — CENTRAL LINE DRESSING CHANGE TRAY (May 12, 1994)
  • K941469 — IV START KIT (May 12, 1994)

Other clearances for product code FRG

  • K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HE (July 2, 2026)
  • K252823 — Dukal Crepe Paper Sterilization Wrap (May 28, 2026)
  • K253454 — HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; (May 18, 2026)
  • 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)

FDA data resources