Cleared Traditional

K024074 - REPROCESSED COMPRESSION SLEEVES (FDA 510(k) Clearance)

Mar 2003
Decision
87d
Days
Class 2
Risk

K024074 is an FDA 510(k) clearance for the REPROCESSED COMPRESSION SLEEVES. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).

Submitted by Alliance Medical Corp. (Phoenix, US). The FDA issued a Cleared decision on March 7, 2003, 87 days after receiving the submission on December 10, 2002.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K024074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2002
Decision Date March 07, 2003
Days to Decision 87 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