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510(k) K955476

DUKAL TRANSPARENT WOUND DRESSING by Dukal Corp. — Product Code MGP

K955476 is an FDA 510(k) premarket notification submitted by Dukal Corp. for the device "DUKAL TRANSPARENT WOUND DRESSING". The FDA issued a decision of SN on January 18, 1996. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Dukal Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
January 18, 1996
Date Received
November 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Occlusive
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Dukal Corp.

  • K252823 — Dukal Crepe Paper Sterilization Wrap (May 28, 2026)
  • K233262 — Dukal SMS Sterilization Wrap (March 22, 2024)
  • K083320 — DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE (March 6, 2009)
  • K070407 — DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE (March 26, 2007)
  • K061864 — DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, (September 15, 2006)
  • K020726 — DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE (May 15, 2002)
  • K984564 — ETHYL CHLORIDE DISPENSER (December 2, 1999)
  • K970455 — DUKAL NON ADHERENT DRESSING (May 8, 1997)
  • K970457 — DUKAL ABD COMBINE PAD (May 8, 1997)
  • K940440 — DUKAL NON-WOVEN GAUZE (March 9, 1994)

Other clearances for product code MGP

  • K012995 — COLLATEK SHEET (October 25, 2001)
  • K012997 — COLLATEK FOAM (October 25, 2001)
  • K001508 — LASERSKIN DRESSING (July 25, 2001)
  • K990079 — FASTSEAL CHEST WOUND DRESSING (December 23, 1999)
  • K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING (October 14, 1999)
  • K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (September 14, 1999)
  • K992005 — GILTECH PLUS TRANSPARENT DRESSING (September 3, 1999)
  • K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (May 27, 1999)
  • K990438 — DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSI (March 25, 1999)
  • K984371 — MEPITEL NON ADHERENT SILICONE DRESSING (March 3, 1999)

FDA data resources