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510(k) K970455

DUKAL NON ADHERENT DRESSING by Dukal Corp. — Product Code EFQ

K970455 is an FDA 510(k) premarket notification submitted by Dukal Corp. for the device "DUKAL NON ADHERENT DRESSING". The FDA issued a decision of Substantially Equivalent on May 8, 1997. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Dukal Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1997
Date Received
February 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal
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)
  • K970457 — DUKAL ABD COMBINE PAD (May 8, 1997)
  • K955476 — DUKAL TRANSPARENT WOUND DRESSING (January 18, 1996)
  • K940440 — DUKAL NON-WOVEN GAUZE (March 9, 1994)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)

FDA data resources