Cleared Traditional

MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT

K083796 · Miltex, Inc. · Dental

Mar 2009

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K083796 is an FDA 510(k) clearance for the MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT, a Syringe, Cartridge (Class II — Special Controls, product code EJI), submitted by Miltex, Inc. (York, US). The FDA issued a Cleared decision on March 9, 2009, 77 days after receiving the submission on December 22, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.6770.

Submission Details

510(k) Number	K083796 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2008
Decision Date	March 09, 2009
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF