Cleared Traditional

MAR-MED LIVER STRAP

K924223 · Mar-Med Co. · General & Plastic Surgery
Mar 1993
Decision
209d
Days
Class 1
Risk

About This 510(k) Submission

K924223 is an FDA 510(k) clearance for the MAR-MED LIVER STRAP, a Clamp, Surgical, General & Plastic Surgery (Class I — General Controls, product code GDJ), submitted by Mar-Med Co. (Grand Rapids, US). The FDA issued a Cleared decision on March 18, 1993, 209 days after receiving the submission on August 21, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K924223 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 1992
Decision Date March 18, 1993
Days to Decision 209 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GDJ — Clamp, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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