Cleared Traditional

ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001

K020592 · Alba-Waldensian, Inc. · General Hospital

Apr 2002

Decision

40d

Days

Class 2

Risk

About This 510(k) Submission

K020592 is an FDA 510(k) clearance for the ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001, a Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (Class II — Special Controls, product code DWL), submitted by Alba-Waldensian, Inc. (Rockwood, US). The FDA issued a Cleared decision on April 3, 2002, 40 days after receiving the submission on February 22, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5780.

Submission Details

510(k) Number	K020592 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 2002
Decision Date	April 03, 2002
Days to Decision	40 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	DWL — Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5780