Cleared Traditional

EAGLE

K950309 · Aalba Dent, Inc. · Dental
Feb 1995
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K950309 is an FDA 510(k) clearance for the EAGLE, a Syringe, Cartridge (Class II — Special Controls, product code EJI), submitted by Aalba Dent, Inc. (Fairfield, US). The FDA issued a Cleared decision on February 16, 1995, 22 days after receiving the submission on January 25, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.6770.

Submission Details

510(k) Number K950309 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1995
Decision Date February 16, 1995
Days to Decision 22 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJI — Syringe, Cartridge
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6770

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