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510(k) K110757

TL-CERMIDE SKIN BARRIER EMULSION by Trigen Laboratories, Inc. — Product Code FRO

K110757 is an FDA 510(k) premarket notification submitted by Trigen Laboratories, Inc. for the device "TL-CERMIDE SKIN BARRIER EMULSION". The FDA issued a decision of Substantially Equivalent on August 19, 2011. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Trigen Laboratories, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2011
Date Received
March 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Trigen Laboratories, Inc.

  • K121134 — TL TRISEB CREAM (July 25, 2012)
  • K110762 — AVO BARRIER TOPICAL EMULSION (November 18, 2011)

Other clearances for product code FRO

  • K254041 — SkinSmart Antimicrobial HydroGel (September 11, 2026)
  • K261646 — Redermax® Antibacterial Wound Matrix (August 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (August 11, 2026)
  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)

FDA data resources