Cleared Traditional

SOF. PRESS EPC 51 SYSTEM

K963067 · Gaymar Industries, Inc. · Cardiovascular
Jan 1997
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K963067 is an FDA 510(k) clearance for the SOF. PRESS EPC 51 SYSTEM, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Gaymar Industries, Inc. (Orchard Park, US). The FDA issued a Cleared decision on January 28, 1997, 174 days after receiving the submission on August 7, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K963067 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 1996
Decision Date January 28, 1997
Days to Decision 174 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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