Home / 510(k) Clearances / K971482

510(k) K971482

DEGANIA SILICONE SIL-K by Degania Silicone , Ltd. — Product Code MDA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1997
Date Received
April 21, 1997
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 Degania Silicone , Ltd.

  • K233591 — Stylus (May 31, 2024)
  • K152246 — Aquarius Stoma Measuring Device (June 21, 2016)
  • K143378 — AQUARIUS Gastrostomy Replacement Tube (December 29, 2014)
  • K141753 — AQUARIUS NASAL FEEDING TUBE (October 16, 2014)
  • K141631 — AQUARIUS EXTENSION FEEDING SET (July 28, 2014)
  • K132686 — AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE (May 12, 2014)
  • K131020 — TEMPERATURE SENSOR CATHETER (May 9, 2013)
  • K122030 — LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON (September 5, 2012)
  • K103371 — COUDE/ OR TIEMANN (March 11, 2011)
  • K070124 — GASTROSTOMY REPLACEMENT TUBE, MODEL 253 (May 23, 2007)

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)