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510(k) K050158

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

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)

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