Cleared Traditional

K020781 - WET CHAMBER
(FDA 510(k) Clearance)

K020781 · Kinetic Concepts, Inc. · General & Plastic Surgery

May 2002

Decision

56d

Days

Class 1

Risk

K020781 is an FDA 510(k) clearance for the WET CHAMBER, a Dressing, Wound, Occlusive (Class I — General Controls, product code NAD), submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 6, 2002, 56 days after receiving the submission on March 11, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4020.

Submission Details

510(k) Number	K020781 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 2002
Decision Date	May 06, 2002
Days to Decision	56 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF