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510(k) K980863

DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) by Dumex Medical Surgical Products, Ltd. — Product Code KMF

K980863 is an FDA 510(k) premarket notification submitted by Dumex Medical Surgical Products, Ltd. for the device "DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)". The FDA issued a decision of Substantially Equivalent on May 11, 1998. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Dumex Medical Surgical Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1998
Date Received
March 5, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
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)
  • 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 KMF

  • K241916 — TearRepair Liquid Skin Protectant (September 27, 2024)
  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K171148 — Aleo BME Liquid Bandage (January 12, 2018)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)
  • K131384 — KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (August 7, 2014)
  • K133443 — MARATHON NO STING LIQUID SKIN PROTECTANT (July 10, 2014)
  • K120059 — LIQUID BANDAGE (May 17, 2012)
  • K092712 — SKIN BARRIER FILM (February 23, 2010)
  • K083087 — ECOCEL (August 7, 2009)

FDA data resources