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510(k) K943470

BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTS by Levtrade Intl. (Pty) , Ltd. — Product Code MGQ

K943470 is an FDA 510(k) premarket notification submitted by Levtrade Intl. (Pty) , Ltd. for the device "BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTS". The FDA issued a decision of SN on September 27, 1994. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Levtrade Intl. (Pty) , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
September 27, 1994
Date Received
July 19, 1994
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 Levtrade Intl. (Pty) , Ltd.

  • K943728 — BURNFREE BURNSOOTHE HYDROGEL (September 27, 1994)
  • K921471 — BURNSHIELD TRAUMA DRESSING (April 20, 1993)
  • K921470 — BURNSHIELD FIRE BLANKET (April 20, 1993)

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