Home / 510(k) Clearances / K050158

510(k) K050158

SINCLAIR SEBORRHEA EMULSION by Sinclair Pharmaceuticals, Ltd. — Product Code FRO

K050158 is an FDA 510(k) premarket notification submitted by Sinclair Pharmaceuticals, Ltd. for the device "SINCLAIR SEBORRHEA EMULSION". The FDA issued a decision of Substantially Equivalent on October 11, 2006. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Sinclair Pharmaceuticals, Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2006
Date Received
January 25, 2005
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 Sinclair Pharmaceuticals, Ltd.

  • K042722 — ALOCLAIR ORAL SPRAY (January 13, 2005)
  • K040950 — ALOCLAIR ORAL GEL (June 21, 2004)
  • K024148 — SALINUM, ORCLAIR (September 15, 2003)
  • K024367 — SINCLAIR WOUND AND SKIN EMULSION (July 28, 2003)
  • K023046 — SST SALIVA SUPPORTING TABLETS (December 2, 2002)
  • K023155 — ALOCLAIR ORAL RINSE (November 25, 2002)
  • K013056 — GELCLAIR CONCENTRATED ORAL GEL (December 21, 2001)

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