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510(k) K982051

KELOCATE SHEETING by Allied Biomedical Corp. — Product Code MDA

K982051 is an FDA 510(k) premarket notification submitted by Allied Biomedical Corp. for the device "KELOCATE SHEETING". The FDA issued a decision of Substantially Equivalent on August 5, 1998. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Allied Biomedical Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1998
Date Received
June 11, 1998
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.

  • K971478 — DURALASTIC ANATOMICAL CHIN IMPLANTS (July 18, 1997)
  • K971479 — DURALASTIC ANATOMICAL MALAR 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)
  • K954413 — KELOCOTE (November 29, 1995)

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