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510(k) K931005

DUKAL SKIN CLOSURE STRIP by Dukal Corp. — Product Code FPX

K931005 is an FDA 510(k) premarket notification submitted by Dukal Corp. for the device "DUKAL SKIN CLOSURE STRIP". The FDA issued a decision of Substantially Equivalent on July 14, 1993. The device falls under product code FPX (Strip, Adhesive, Closure, Skin), a Class I device regulated under 21 CFR 880.5240. Dukal Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1993
Date Received
February 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Adhesive, Closure, Skin
Device Class
Class I
Regulation Number
880.5240
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)
  • K970455 — DUKAL NON ADHERENT DRESSING (May 8, 1997)
  • K955476 — DUKAL TRANSPARENT WOUND DRESSING (January 18, 1996)

Other clearances for product code FPX

  • K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH (May 9, 1997)
  • K952947 — DELPORE SKIN CLOSURE (July 24, 1995)
  • K952702 — DERMA SEAL (June 28, 1995)
  • K946321 — BIOSTRIP STERILE WOUND CLOSURE STRIP (January 12, 1995)
  • K921775 — SPYROFLEX WOUND CLOSURES (May 19, 1992)
  • K894802 — AWC BUTTERFLY WOUND CLOSURES (January 31, 1990)
  • K894205 — TECNOL SILK STRIP (July 25, 1989)
  • K874813 — OMED WOUND CLOSURE STRIPS (January 29, 1988)
  • K840945 — SKIN CLOSURE (October 31, 1984)
  • K842621 — SUTURE STRIP (October 25, 1984)

FDA data resources