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510(k) K980861

DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL by Dumex Medical Surgical Products, Ltd. — Product Code MGQ

K980861 is an FDA 510(k) premarket notification submitted by Dumex Medical Surgical Products, Ltd. for the device "DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL". The FDA issued a decision of Substantially Equivalent on May 20, 1998. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), 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
May 20, 1998
Date Received
March 5, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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)
  • 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)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 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 MGQ

  • K171879 — HylaGuard Moisturizing Cream (October 16, 2017)
  • K083024 — HYLATOPIC EMOLLIENT FOAM (March 27, 2009)
  • K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION (July 19, 2005)
  • K041268 — SILVERSITE OR CALGITROL (September 20, 2004)
  • K040019 — SILVERSEAL (July 23, 2004)
  • K040517 — TENDERWET ACTIVE (March 25, 2004)
  • K022587 — MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (August 22, 2003)
  • K024367 — SINCLAIR WOUND AND SKIN EMULSION (July 28, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (March 7, 2003)
  • K022584 — CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (December 30, 2002)

FDA data resources