Cleared Traditional

EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES

K040671 · Anthogyr · Dental
Dec 2004
Decision
274d
Days
Class 2
Risk

About This 510(k) Submission

K040671 is an FDA 510(k) clearance for the EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES, a Syringe, Cartridge (Class II — Special Controls, product code EJI), submitted by Anthogyr (Sallanches, FR). The FDA issued a Cleared decision on December 14, 2004, 274 days after receiving the submission on March 15, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.6770.

Submission Details

510(k) Number K040671 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2004
Decision Date December 14, 2004
Days to Decision 274 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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

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