MIRAMATIC SAFE SYRINGE SYSTEM— 510(k) K043322

Name: FDA 510(k) clearance K043322
Creator: U.S. Food and Drug Administration
Published: 2005-07-21

Substantially Equivalent

Hager Worldwide, Inc.

FDA 510(k) clearance K043322 for MIRAMATIC SAFE SYRINGE SYSTEM, Substantially Equivalent on 2005-07-21. Applicant: Hager Worldwide, Inc.. Device class: 2.

Clearance details

Applicant: Hager Worldwide, Inc.
Product code: Code EJI
Device class: Class 2
Regulation: 21 CFR 872.6770
Advisory panel: Dental
Date received: 2004-12-02
Decision date: 2005-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJI

view all

K171254 — LeEject 2 Dental Syringe and Needle System2017-11-16
K142414 — Miltex N-Tralig Intraligamentary Syringe2014-10-30
K120659 — HU-FRIEDY DENTAL CARTRIDGE SYRINGE2012-11-06
K113247 — ANESTHESIA INJECTION TOOL SET2012-03-27
K082249 — MORPHEUS2009-12-31

More clearances from Hager Worldwide, Inc.

view all

K061933 — HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER2006-11-16
K050658 — RESO-PAC PERIODONTAL DRESSING2005-05-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.