Cleared Traditional

GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST

K914913 · Ideal Medical, Inc. · General & Plastic Surgery
Dec 1991
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K914913 is an FDA 510(k) clearance for the GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST, a Clamp, Surgical, General & Plastic Surgery (Class I — General Controls, product code GDJ), submitted by Ideal Medical, Inc. (Clearwater, US). The FDA issued a Cleared decision on December 31, 1991, 60 days after receiving the submission on November 1, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K914913 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 1991
Decision Date December 31, 1991
Days to Decision 60 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GDJ — Clamp, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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