Cleared Traditional

THE POREX RETRACTOR TABLE

K860503 · Porex Medical · General & Plastic Surgery
Mar 1986
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K860503 is an FDA 510(k) clearance for the THE POREX RETRACTOR TABLE, a Table, Operating-room, Manual (Class I — General Controls, product code FSE), submitted by Porex Medical (Fairburn, US). The FDA issued a Cleared decision on March 13, 1986, 30 days after receiving the submission on February 11, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number K860503 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1986
Decision Date March 13, 1986
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FSE — Table, Operating-room, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4950

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