Cleared Traditional

HU-FRIEDY DENTAL CARTRIDGE SYRINGE

K120659 · Hu-Friedy Mfg. Co., LLC · Dental

Nov 2012

Decision

246d

Days

Class 2

Risk

About This 510(k) Submission

K120659 is an FDA 510(k) clearance for the HU-FRIEDY DENTAL CARTRIDGE SYRINGE, a Syringe, Cartridge (Class II — Special Controls, product code EJI), submitted by Hu-Friedy Mfg. Co., LLC (Chicago, US). The FDA issued a Cleared decision on November 6, 2012, 246 days after receiving the submission on March 5, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.6770.

Submission Details

510(k) Number	K120659 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 2012
Decision Date	November 06, 2012
Days to Decision	246 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF