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510(k) K024057

CURAD SCAR THERAPY by Beiersdorf, Inc. — Product Code MDA

K024057 is an FDA 510(k) premarket notification submitted by Beiersdorf, Inc. for the device "CURAD SCAR THERAPY". The FDA issued a decision of Substantially Equivalent on June 18, 2003. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Beiersdorf, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2003
Date Received
December 9, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elastomer, Silicone, For Scar Management
Device Class
Class I
Regulation Number
878.4025
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)
  • K032463 — CURAD SILVER BANDAGE (February 10, 2004)
  • K032462 — CURAD SILVER ACTIVE GEL BANDAGE (February 10, 2004)
  • 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)
  • K925630 — ELASTOPLAST HEAT PLASTER (February 25, 1994)

Other clearances for product code MDA

  • K112131 — NEODYNE DRESSING (September 29, 2011)
  • K111733 — CORELEADER SCAR-DIMMER (September 22, 2011)
  • K083718 — BEAU RX SCAR CARE GEL (January 26, 2009)
  • K053481 — KELO-COTE SPRAY (April 14, 2006)
  • K041704 — NEWGEL AND NEWGEL PLUS E (October 17, 2005)
  • K040307 — HANSON SCAR ADE (August 12, 2004)
  • K024160 — NEOSPORIN SCAR SOLUTION (March 17, 2003)
  • K023678 — DIMISIL SCAR GEL (January 23, 2003)
  • K023136 — OLEEVA FABRIC (October 16, 2002)
  • K014036 — MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILIC (February 14, 2002)

FDA data resources