Cleared Traditional

K900441 - BURNS CASUALTY SHEET
(FDA 510(k) Clearance)

K900441 · Pilgrim Medical Services · General & Plastic Surgery device

Jul 1990

Decision

154d

Days

Class 1

Risk

K900441 is an FDA 510(k) clearance for the BURNS CASUALTY SHEET. This device is classified as a Sheet, Burn (Class I - General Controls, product code FPY).

Submitted by Pilgrim Medical Services (England Hr2 6sx, GB). The FDA issued a Cleared decision on July 3, 1990, 154 days after receiving the submission on January 30, 1990.

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

Submission Details

510(k) Number	K900441 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 30, 1990
Decision Date	July 03, 1990
Days to Decision	154 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—