Cleared Traditional

DISPOSABLE FLOOR INSTRUMENTS

K831911 · Ormed Mfg., Inc. · General & Plastic Surgery
Sep 1983
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K831911 is an FDA 510(k) clearance for the DISPOSABLE FLOOR INSTRUMENTS, a Instrument, Surgical, Disposable (Class I — General Controls, product code KDC), submitted by Ormed Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983, 90 days after receiving the submission on June 14, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K831911 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1983
Decision Date September 12, 1983
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KDC — Instrument, Surgical, Disposable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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