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510(k) K953450

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

K953450 is an FDA 510(k) premarket notification submitted by Dpt Laboratories, Ltd. for the device "CURASOL GEL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on Aug 7, 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
SESE (Substantially Equivalent)
Decision Date
Aug 7, 1995
Date Received
Jul 18, 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)
  • K953816 — DCURASOL GEL WOUND DRESSING (Aug 28, 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 K953450. Report a data issue: hello@regdatalab.com.