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510(k) K971009

SCAR CARE by Target Health, Inc. — Product Code MDA

K971009 is an FDA 510(k) premarket notification submitted by Target Health, Inc. for the device "SCAR CARE". The FDA issued a decision of Substantially Equivalent on July 29, 1997. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Target Health, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1997
Date Received
March 20, 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 Target Health, Inc.

  • K971549 — VMT SYSTEM (October 5, 1998)
  • K973271 — SKAR-KARE (November 19, 1997)

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