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510(k) K972458

LYOCELL WOUND DRESSING/SURGICAL SPONGE by Courtaulds Fibers, Inc. — Product Code MGP

K972458 is an FDA 510(k) premarket notification submitted by Courtaulds Fibers, Inc. for the device "LYOCELL WOUND DRESSING/SURGICAL SPONGE". The FDA issued a decision of Substantially Equivalent on September 19, 1997. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Courtaulds Fibers, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1997
Date Received
July 1, 1997
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 Courtaulds Fibers, Inc.

  • K932846 — TENCEL X-RAY DETECTABLE SPONGES/LAP PADS (December 9, 1993)
  • K921227 — TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE (May 29, 1992)

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