Cleared Traditional

WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE

K942630 · Mill-Rose Laboratory · Gastroenterology & Urology
Jul 1994
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K942630 is an FDA 510(k) clearance for the WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on July 12, 1994, 39 days after receiving the submission on June 3, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K942630 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1994
Decision Date July 12, 1994
Days to Decision 39 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KNW — Instrument, Biopsy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1075

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