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510(k) K953816

DCURASOL GEL WOUND DRESSING by Dpt Laboratories, Ltd. — Product Code MGQ

K953816 is an FDA 510(k) premarket notification submitted by Dpt Laboratories, Ltd. for the device "DCURASOL GEL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent for Some Indications on Aug 28, 1995. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Dpt Laboratories, Ltd. has 2 other 510(k) clearances on record.

Clearance Details

Decision
SN (Substantially Equivalent for Some Indications)
Decision Date
Aug 28, 1995
Date Received
Aug 15, 1995
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
Review Panel
SU
Submission Type
510(k)

Other clearances by Dpt Laboratories, Ltd.

  • K965120 — ALLCLENZ WOUND CLEANSER (Mar 21, 1997)
  • K953450 — CURASOL GEL WOUND DRESSING (Aug 7, 1995)

Other clearances for product code MGQ

  • K171879 — HylaGuard Moisturizing Cream (Oct 16, 2017)
  • K083024 — HYLATOPIC EMOLLIENT FOAM (Mar 27, 2009)
  • K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION (Jul 19, 2005)
  • K041268 — SILVERSITE OR CALGITROL (Sep 20, 2004)
  • K040019 — SILVERSEAL (Jul 23, 2004)
  • K040517 — TENDERWET ACTIVE (Mar 25, 2004)
  • K022587 — MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (Aug 22, 2003)
  • K024367 — SINCLAIR WOUND AND SKIN EMULSION (Jul 28, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (Mar 7, 2003)
  • K022584 — CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (Dec 30, 2002)

FDA data resources

Source: FDA 510(k) database entry for K953816. Report a data issue: hello@regdatalab.com.