Cleared Traditional

REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS

K022753 · Medical Device Services · Cardiovascular
Nov 2002
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K022753 is an FDA 510(k) clearance for the REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Medical Device Services (St. George, US). The FDA issued a Cleared decision on November 14, 2002, 87 days after receiving the submission on August 19, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K022753 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2002
Decision Date November 14, 2002
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

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