Cleared Traditional

RIB RESECTOR

K951492 · United States Surgical, A Division of Tyco Healthc · Neurology
May 1995
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K951492 is an FDA 510(k) clearance for the RIB RESECTOR, a Instrument, Surgical, Non-powered (Class I — General Controls, product code HAO), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on May 18, 1995, 48 days after receiving the submission on March 31, 1995. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4535.

Submission Details

510(k) Number K951492 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1995
Decision Date May 18, 1995
Days to Decision 48 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAO — Instrument, Surgical, Non-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 882.4535

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