Home / 510(k) Clearances / K955664

510(k) K955664

STERILIZED TRI BLOCK POLYMER GEL SHEET by Silipos, Inc. — Product Code MDA

K955664 is an FDA 510(k) premarket notification submitted by Silipos, Inc. for the device "STERILIZED TRI BLOCK POLYMER GEL SHEET". The FDA issued a decision of Substantially Equivalent on February 28, 1996. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Silipos, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1996
Date Received
December 13, 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 Silipos, Inc.

  • K944240 — SOFT SOCK (December 27, 1994)
  • K942695 — TRI BLOCK POLUMER GEL SHEETING (November 10, 1994)
  • K932048 — SILICONE GEL SHEETING (January 7, 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)
  • 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