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510(k) K925583

JOBSKIN CONTINUING CARE by Jobst Institute, Inc. — Product Code MDA

K925583 is an FDA 510(k) premarket notification submitted by Jobst Institute, Inc. for the device "JOBSKIN CONTINUING CARE". The FDA issued a decision of Substantially Equivalent on April 4, 1994. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Jobst Institute, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1994
Date Received
November 5, 1992
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 Jobst Institute, Inc.

  • K955138 — ANTI-EM/GP STOCKINGS (December 13, 1995)
  • K953763 — GLADIATOR ANTISHOCK PANTS (November 28, 1995)
  • K925154 — JOBST-CUSTOM (April 4, 1994)
  • K934639 — JOBST ATHROMBIC PUMP - SYSTEM 2500 (February 9, 1994)
  • K922681 — CUTINOVA FOAM (August 31, 1992)
  • K921562 — JOBST EXTREMITY PUMP SYSTEM 7500 (June 22, 1992)
  • K920444 — ULTIMATE (April 20, 1992)
  • K912232 — ULCERCARE (August 14, 1991)
  • K911247 — YOURS TRULY ASYMMETRICAL BREAST FORM (March 29, 1991)
  • K905631 — COMPRINET, COMTESSE AND BELLAVAR STOCKINGS (March 7, 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