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510(k) K961085

DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING by Debusk Knitting Mills, Div. Deroyal Industries — Product Code MGQ

K961085 is an FDA 510(k) premarket notification submitted by Debusk Knitting Mills, Div. Deroyal Industries for the device "DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on May 21, 1996. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Debusk Knitting Mills, Div. Deroyal Industries has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1996
Date Received
March 19, 1996
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 Debusk Knitting Mills, Div. Deroyal Industries

  • K961097 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES (June 3, 1996)
  • K961087 — DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS (May 16, 1996)
  • K954716 — DEROYAL INDUSTRIES INFANT HEEL WARMER (January 11, 1996)

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)
  • K024367 — SINCLAIR WOUND AND SKIN EMULSION (July 28, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (March 7, 2003)
  • K022584 — CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (December 30, 2002)

FDA data resources