Cleared Traditional

K760579 - INSTRUMENT RACK FOR DAWSON-YUHL INSTR. (FDA 510(k) Clearance)

Nov 1976
Decision
60d
Days
Class 1
Risk

K760579 is an FDA 510(k) clearance for the INSTRUMENT RACK FOR DAWSON-YUHL INSTR.. This device is classified as a Tray, Surgical, Instrument (Class I - General Controls, product code FSM).

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1976, 60 days after receiving the submission on September 3, 1976.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K760579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1976
Decision Date November 02, 1976
Days to Decision 60 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

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