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510(k) K041268

SILVERSITE OR CALGITROL by Adri — Product Code MGQ

K041268 is an FDA 510(k) premarket notification submitted by Adri for the device "SILVERSITE OR CALGITROL". The FDA issued a decision of Substantially Equivalent on September 20, 2004. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Adri has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2004
Date Received
May 12, 2004
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 Adri

  • K011618 — CALGITROL AG SILVER ALGINATE WOUND DRESSING (November 15, 2002)
  • K000054 — FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN (March 13, 2000)
  • K963656 — FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING (November 12, 1996)
  • K940404 — ALGINATE FIBER TOPICAL WOUND DRESSING (May 4, 1994)
  • K870383 — ALGINATE WOOL FIBER (April 30, 1987)

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)
  • 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)
  • K022995 — COLLATEK HYDROGEL (December 2, 2002)

FDA data resources