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510(k) K926399

CUTIFILM(R) FILM by Beiersdorf, Inc. — Product Code MGP

K926399 is an FDA 510(k) premarket notification submitted by Beiersdorf, Inc. for the device "CUTIFILM(R) FILM". The FDA issued a decision of Substantially Equivalent on November 15, 1993. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Beiersdorf, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1993
Date Received
December 21, 1992
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 Beiersdorf, Inc.

  • K090921 — ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, (December 18, 2009)
  • K032462 — CURAD SILVER ACTIVE GEL BANDAGE (February 10, 2004)
  • K032463 — CURAD SILVER BANDAGE (February 10, 2004)
  • K024057 — CURAD SCAR THERAPY (June 18, 2003)
  • K022645 — CURAD (November 5, 2002)
  • K952526 — CUTINOVA CAVITY (August 14, 1995)
  • K943363 — CUTIPLAST STERIL (March 15, 1995)
  • K944581 — CUTINOVA THIN WOUND DRESSING (December 2, 1994)
  • K935630 — NORTA (October 7, 1994)
  • K940378 — COVERLET ADHESIVE DRESSING (July 29, 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