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510(k) K980791

DUMEX PAK-ITS WOVEN RIBBON PACKING by Dumex Medical Surgical Products, Ltd. — Product Code EFQ

K980791 is an FDA 510(k) premarket notification submitted by Dumex Medical Surgical Products, Ltd. for the device "DUMEX PAK-ITS WOVEN RIBBON PACKING". The FDA issued a decision of Substantially Equivalent on April 29, 1998. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Dumex Medical Surgical Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1998
Date Received
March 2, 1998
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 Dumex Medical Surgical Products, Ltd.

  • K992732 — STERILE WATER & STERILE 0.9% SODIUM CHLORIDE (April 20, 2000)
  • K993119 — STERILE HYDROGEL (November 23, 1999)
  • K990332 — DUMEX IODOFORM PACKING STRIP (April 14, 1999)
  • K980779 — THALAFIX NATURAL SEA SALT DRESSING (June 26, 1998)
  • K980861 — DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL (May 20, 1998)
  • K980863 — DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) (May 11, 1998)
  • K980777 — DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING (May 4, 1998)
  • K960815 — DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSIN (April 29, 1996)
  • K950132 — DUMEX WET DRESSINGS (March 1, 1995)
  • K946326 — DUTEX GAUZE BANDAGE (January 24, 1995)

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)
  • K974316 — HYDROFERA FEMORAL WICK (February 13, 1998)

FDA data resources