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510(k) K980777

DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING by Dumex Medical Surgical Products, Ltd. — Product Code FRO

K980777 is an FDA 510(k) premarket notification submitted by Dumex Medical Surgical Products, Ltd. for the device "DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING". The FDA issued a decision of Substantially Equivalent on May 4, 1998. The device falls under product code FRO (Dressing, Wound, Drug), 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 4, 1998
Date Received
March 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
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)
  • 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 FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources