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510(k) K970702

SPECTRUM DESIGNS SPECTRAGEL by Spectrum Designs, Inc. — Product Code MDA

K970702 is an FDA 510(k) premarket notification submitted by Spectrum Designs, Inc. for the device "SPECTRUM DESIGNS SPECTRAGEL". The FDA issued a decision of Substantially Equivalent on May 12, 1997. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Spectrum Designs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1997
Date Received
February 26, 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 Spectrum Designs, Inc.

  • K992522 — SPECTRUM DESIGNS SPECTRAGEL (October 26, 1999)
  • K982688 — SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK (October 13, 1998)
  • K980446 — SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT (May 6, 1998)
  • K980444 — SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT (May 6, 1998)
  • K980462 — SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT (May 6, 1998)
  • K980445 — SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT (May 6, 1998)
  • K980463 — SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT (May 6, 1998)
  • K980138 — SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT (April 3, 1998)
  • K980461 — SPECTRUM DESIGNS CLEFT CHIN IMPLANT (March 4, 1998)
  • K980141 — SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (March 3, 1998)

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