Cleared Traditional

K830593 - ENSURE DRESSING
(FDA 510(k) Clearance)

K830593 · Warner-Lambert Co. · General & Plastic Surgery

Apr 1983

Decision

41d

Days

Class 1

Risk

K830593 is an FDA 510(k) clearance for the ENSURE DRESSING, a Dressing, Wound, Occlusive (Class I — General Controls, product code NAD), submitted by Warner-Lambert Co. (Mchenry, US). The FDA issued a Cleared decision on April 6, 1983, 41 days after receiving the submission on February 24, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4020.

Submission Details

510(k) Number	K830593 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 1983
Decision Date	April 06, 1983
Days to Decision	41 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—