Cleared Traditional

K922143 - AMERICAN BURN SHEET
(FDA 510(k) Clearance)

K922143 · American Silk Sutures, Inc. · General Hospital

Aug 1992

Decision

96d

Days

Class 1

Risk

K922143 is an FDA 510(k) clearance for the AMERICAN BURN SHEET. This device is classified as a Bedding, Disposable, Medical (Class I - General Controls, product code KME).

Submitted by American Silk Sutures, Inc. (Lynn, US). The FDA issued a Cleared decision on August 10, 1992, 96 days after receiving the submission on May 6, 1992.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6060.

Submission Details

510(k) Number	K922143 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 06, 1992
Decision Date	August 10, 1992
Days to Decision	96 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement