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510(k) K003979

MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD by Medtrade Products , Ltd. — Product Code MDA

K003979 is an FDA 510(k) premarket notification submitted by Medtrade Products , Ltd. for the device "MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD". The FDA issued a decision of Substantially Equivalent on March 19, 2001. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Medtrade Products , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2001
Date Received
December 22, 2000
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 Medtrade Products , Ltd.

  • K230589 — Celox Rapid X-Ray Gauze (November 17, 2023)
  • K161274 — Bondiloxs Topical Hemostatic Granules (January 18, 2017)
  • K132333 — BONDILOXS TOPICAL HEMOSTATIC DRESSING (June 25, 2014)
  • K120930 — CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM (October 26, 2012)
  • K113560 — CELOX GAUZE PRO (August 1, 2012)
  • K110386 — CELOX RAPID GAUZE (May 10, 2011)
  • K102965 — CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TR (December 8, 2010)
  • K093519 — MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET (January 14, 2010)
  • K090780 — MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE (November 20, 2009)
  • K091795 — MEDTRADE PRODUCTS CELOX TRAUMA GAUZE (November 20, 2009)

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)
  • K024057 — CURAD SCAR THERAPY (June 18, 2003)
  • K024160 — NEOSPORIN SCAR SOLUTION (March 17, 2003)
  • K023678 — DIMISIL SCAR GEL (January 23, 2003)
  • K023136 — OLEEVA FABRIC (October 16, 2002)

FDA data resources