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510(k) K921471

BURNSHIELD TRAUMA DRESSING by Levtrade Intl. (Pty) , Ltd. — Product Code FPY

K921471 is an FDA 510(k) premarket notification submitted by Levtrade Intl. (Pty) , Ltd. for the device "BURNSHIELD TRAUMA DRESSING". The FDA issued a decision of Substantially Equivalent on April 20, 1993. The device falls under product code FPY (Sheet, Burn), a Class I device regulated under 21 CFR 880.5180. Levtrade Intl. (Pty) , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1993
Date Received
March 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sheet, Burn
Device Class
Class I
Regulation Number
880.5180
Review Panel
SU
Submission Type

Other clearances by Levtrade Intl. (Pty) , Ltd.

  • K943728 — BURNFREE BURNSOOTHE HYDROGEL (September 27, 1994)
  • K943470 — BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTS (September 27, 1994)
  • K921470 — BURNSHIELD FIRE BLANKET (April 20, 1993)

Other clearances for product code FPY

  • K930759 — CP & S STERILE BURN SHEET (January 21, 1994)
  • K921470 — BURNSHIELD FIRE BLANKET (April 20, 1993)
  • K926290 — BURN SHEET (April 20, 1993)
  • K900441 — BURNS CASUALTY SHEET (July 3, 1990)
  • K900443 — BURNS CASUALTY SHEET LIMB WRAP (July 3, 1990)
  • K900442 — BURNS CASUALTY SHEET BURN ROLL (July 3, 1990)
  • K871740 — LYOSHEET SURGICAL SHEET FOR BURNS (June 9, 1987)
  • K853145 — KENDALL CURITY BURN PAD (August 30, 1985)
  • K841898 — FIRST RESPONSE EMERG. MEDICSL - BURNS (August 14, 1984)
  • K820994 — ABSORB FURN SHEET (May 13, 1982)

FDA data resources