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510(k) K041704

NEWGEL AND NEWGEL PLUS E by Newmedical Technology, Inc. — Product Code MDA

K041704 is an FDA 510(k) premarket notification submitted by Newmedical Technology, Inc. for the device "NEWGEL AND NEWGEL PLUS E". The FDA issued a decision of Substantially Equivalent on October 17, 2005. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Newmedical Technology, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2005
Date Received
June 23, 2004
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 Newmedical Technology, Inc.

  • K040064 — NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR (March 23, 2004)
  • K030485 — NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR (December 3, 2003)

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)
  • 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)
  • K014036 — MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILIC (February 14, 2002)

FDA data resources