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510(k) K945892

SILON(R) SILICONE THERMOPLASTIC SHEETING by Bio Med Sciences, Inc. — Product Code MDA

K945892 is an FDA 510(k) premarket notification submitted by Bio Med Sciences, Inc. for the device "SILON(R) SILICONE THERMOPLASTIC SHEETING". The FDA issued a decision of Substantially Equivalent on March 3, 1995. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Bio Med Sciences, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1995
Date Received
December 2, 1994
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 Bio Med Sciences, Inc.

  • K023136 — OLEEVA FABRIC (October 16, 2002)
  • K002109 — OLEEVA FOAM (August 31, 2000)
  • K990042 — SILON DUAL-DRESS (March 19, 1999)
  • K982036 — SILON SCAR STRIPS (August 6, 1998)
  • K952546 — SILON SILICONE TEXTILE COMPOSITE (August 7, 1995)
  • K946362 — SILON SILICONE FOAM SHEETING (July 13, 1995)
  • K932214 — SILON SILICONE GEL SHEET (January 6, 1994)
  • K923150 — SILON TRANSPARENT WOUND DRESSINGS (August 27, 1992)
  • K912032 — SILON(TM) TRANSPARENT WOUND DRESSING (August 20, 1991)

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