Cleared Traditional

PRESSSION S III

K942796 · Chattanooga Group, Inc. · Cardiovascular
Mar 1995
Decision
283d
Days
Class 2
Risk

About This 510(k) Submission

K942796 is an FDA 510(k) clearance for the PRESSSION S III, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Chattanooga Group, Inc. (Hixson, US). The FDA issued a Cleared decision on March 24, 1995, 283 days after receiving the submission on June 14, 1994. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K942796 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1994
Decision Date March 24, 1995
Days to Decision 283 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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