Cleared Traditional

K920339 - DRESSING CHANGE TRAY
(FDA 510(k) Clearance)

K920339 · Medikmark, Inc. · General Hospital

Apr 1992

Decision

90d

Days

Class 2

Risk

K920339 is an FDA 510(k) clearance for the DRESSING CHANGE TRAY, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Medikmark, Inc. (Chicago, US). The FDA issued a Cleared decision on April 23, 1992, 90 days after receiving the submission on January 24, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K920339 FDA.gov
FDA Decision	Cleared SEKD
Date Received	January 24, 1992
Decision Date	April 23, 1992
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement