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510(k) K024367

SINCLAIR WOUND AND SKIN EMULSION by Sinclair Pharmaceuticals, Ltd. — Product Code MGQ

K024367 is an FDA 510(k) premarket notification submitted by Sinclair Pharmaceuticals, Ltd. for the device "SINCLAIR WOUND AND SKIN EMULSION". The FDA issued a decision of Substantially Equivalent on July 28, 2003. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), 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
July 28, 2003
Date Received
December 31, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Sinclair Pharmaceuticals, Ltd.

  • K050158 — SINCLAIR SEBORRHEA EMULSION (October 11, 2006)
  • K042722 — ALOCLAIR ORAL SPRAY (January 13, 2005)
  • K040950 — ALOCLAIR ORAL GEL (June 21, 2004)
  • K024148 — SALINUM, ORCLAIR (September 15, 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 MGQ

  • K171879 — HylaGuard Moisturizing Cream (October 16, 2017)
  • K083024 — HYLATOPIC EMOLLIENT FOAM (March 27, 2009)
  • K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION (July 19, 2005)
  • K041268 — SILVERSITE OR CALGITROL (September 20, 2004)
  • K040019 — SILVERSEAL (July 23, 2004)
  • K040517 — TENDERWET ACTIVE (March 25, 2004)
  • K022587 — MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (August 22, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (March 7, 2003)
  • K022584 — CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (December 30, 2002)
  • K022995 — COLLATEK HYDROGEL (December 2, 2002)

FDA data resources