Cleared Traditional

THORACENTISIS KIT

K894326 · Mill-Rose Laboratory · General & Plastic Surgery
Jul 1989
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K894326 is an FDA 510(k) clearance for the THORACENTISIS KIT, a Needle, Aspiration And Injection, Disposable (Class I — General Controls, product code GAA), submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on July 24, 1989, 10 days after receiving the submission on July 14, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K894326 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1989
Decision Date July 24, 1989
Days to Decision 10 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GAA — Needle, Aspiration And Injection, Disposable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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