Cleared Abbreviated

MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM

K003090 · Midmark Corp. · Dental
Oct 2000
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K003090 is an FDA 510(k) clearance for the MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on October 18, 2000, 15 days after receiving the submission on October 3, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K003090 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2000
Decision Date October 18, 2000
Days to Decision 15 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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