Cleared Traditional

ALBA HEALTH PAS WRAP SYSTEM

K961405 · Alba-Waldensian, Inc. · Cardiovascular
Dec 1996
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K961405 is an FDA 510(k) clearance for the ALBA HEALTH PAS WRAP SYSTEM, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Alba-Waldensian, Inc. (Valdese, US). The FDA issued a Cleared decision on December 26, 1996, 259 days after receiving the submission on April 11, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K961405 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1996
Decision Date December 26, 1996
Days to Decision 259 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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