Cleared Traditional

ARTHROSCOPY TRAY

K912106 · Medical Device Inspection Co., Inc. · General & Plastic Surgery
Aug 1991
Decision
108d
Days
Class 1
Risk

About This 510(k) Submission

K912106 is an FDA 510(k) clearance for the ARTHROSCOPY TRAY, a Tray, Surgical, Instrument (Class I — General Controls, product code FSM), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on August 29, 1991, 108 days after receiving the submission on May 13, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K912106 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1991
Decision Date August 29, 1991
Days to Decision 108 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FSM — Tray, Surgical, Instrument
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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