Cleared Traditional

SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE

K851524 · Specialites Septodont · Dental
Sep 1985
Decision
160d
Days
Class 1
Risk

About This 510(k) Submission

K851524 is an FDA 510(k) clearance for the SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE, a Needle, Dental (Class I — General Controls, product code DZM), submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on September 23, 1985, 160 days after receiving the submission on April 16, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.4730.

Submission Details

510(k) Number K851524 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 1985
Decision Date September 23, 1985
Days to Decision 160 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code DZM — Needle, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4730

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