Home / 510(k) Clearances / K945020

510(k) K945020

FLUFF GAUZE SPONGE by Clinical Resources, Inc. — Product Code EFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1994
Date Received
October 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal
Device Class
Class U
Regulation Number
Review Panel
SU
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)
  • K945019 — FLUFF GAUXZE ROLL (December 23, 1994)
  • K944879 — GAUZE SPONGES (December 23, 1994)
  • K945021 — FLUFF GAUZE SPONGE (December 23, 1994)
  • K944880 — BODILY FLUID DISPOSAL KIT (December 15, 1994)
  • K941467 — WOUND DRESSING KIT (May 12, 1994)
  • K941471 — CENTRAL LINE DRESSING CHANGE TRAY (May 12, 1994)
  • K941468 — DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY (May 12, 1994)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)