BURNSHIELD FIRE BLANKET— 510(k) K921470

Name: FDA 510(k) clearance K921470
Creator: U.S. Food and Drug Administration
Published: 1993-04-20

Substantially Equivalent

Levtrade Intl. (Pty) , Ltd.

FDA 510(k) clearance K921470 for BURNSHIELD FIRE BLANKET, Substantially Equivalent on 1993-04-20. Applicant: Levtrade Intl. (Pty) , Ltd.. Device class: 1.

Clearance details

Applicant: Levtrade Intl. (Pty) , Ltd.
Product code: Code FPY
Device class: Class 1
Regulation: 21 CFR 880.5180
Advisory panel: General Hospital
Date received: 1992-03-27
Decision date: 1993-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petoria, South Africa, ZA

Download summary PDF View on FDA.gov ↗

Recent devices under product code FPY

view all

K930759 — CP & S STERILE BURN SHEET1994-01-21
K921471 — BURNSHIELD TRAUMA DRESSING1993-04-20
K926290 — BURN SHEET1993-04-20
K900441 — BURNS CASUALTY SHEET1990-07-03
K900442 — BURNS CASUALTY SHEET BURN ROLL1990-07-03

More clearances from Levtrade Intl. (Pty) , Ltd.

view all

K943470 — BURNFREE BURNSOOTHE HYDROGEL BURN BLOTTS1994-09-27
K943728 — BURNFREE BURNSOOTHE HYDROGEL1994-09-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.