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510(k) K954413

KELOCOTE by Allied Biomedical Corp. — Product Code MDA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1995
Date Received
September 21, 1995
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 Allied Biomedical Corp.

  • K982051 — KELOCATE SHEETING (August 5, 1998)
  • K971479 — DURALASTIC ANATOMICAL MALAR IMPLANTS (July 18, 1997)
  • K971478 — DURALASTIC ANATOMICAL CHIN IMPLANTS (July 18, 1997)
  • K971481 — DURALASTIC ANATOMICAL NASAL IMPLANTS (July 18, 1997)
  • K971480 — DURALASTIC I AND DURALASTIC II (May 28, 1997)
  • K955368 — DURALASTIC I (February 8, 1996)
  • K955370 — DURALASTIC II (February 8, 1996)
  • K955433 — DURALASTIC SILICONE TUBING (January 26, 1996)

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)