Cleared Traditional

K921471 - BURNSHIELD TRAUMA DRESSING
(FDA 510(k) Clearance)

K921471 · Levtrade Intl. (Pty) , Ltd. · General & Plastic Surgery device

Apr 1993

Decision

389d

Days

Class 1

Risk

K921471 is an FDA 510(k) clearance for the BURNSHIELD TRAUMA DRESSING. This device is classified as a Sheet, Burn (Class I - General Controls, product code FPY).

Submitted by Levtrade Intl. (Pty) , Ltd. (Petoria, South Africa, ZA). The FDA issued a Cleared decision on April 20, 1993, 389 days after receiving the submission on March 27, 1992.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5180.

Submission Details

510(k) Number	K921471 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 27, 1992
Decision Date	April 20, 1993
Days to Decision	389 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement