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510(k) K960815

DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL by Dumex Medical Surgical Products, Ltd. — Product Code NAD

K960815 is an FDA 510(k) premarket notification submitted by Dumex Medical Surgical Products, Ltd. for the device "DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL". The FDA issued a decision of Substantially Equivalent on April 29, 1996. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. 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, 1996
Date Received
February 28, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
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)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)
  • K950132 — DUMEX WET DRESSINGS (March 1, 1995)
  • K946326 — DUTEX GAUZE BANDAGE (January 24, 1995)

Other clearances for product code NAD

  • K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL (March 3, 2011)
  • K091133 — APLION TOPICAL CARE SYSTEM (May 20, 2009)
  • K072560 — ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) (June 17, 2008)
  • K080524 — CENTURION SORBAVIEW OTC (April 23, 2008)
  • K060046 — DERMASTREAM (February 27, 2006)
  • K043063 — OXYBAND WOUND DRESSING (March 24, 2005)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K990530 — KERLIX MD ANTIMICROBIAL GAUZE DRESSING (January 31, 2000)
  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K964534 — OTOSILK OTOLOGICAL GRAFT DRESSING (April 9, 1997)

FDA data resources