Cleared Traditional

GRADTECH SYRINGE SYSTEM

K864732 · Gradtech · Dental

Apr 1987

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K864732 is an FDA 510(k) clearance for the GRADTECH SYRINGE SYSTEM, a Injector, Jet, Mechanical-powered (Class II — Special Controls, product code EGM), submitted by Gradtech (Tucson, US). The FDA issued a Cleared decision on April 15, 1987, 132 days after receiving the submission on December 4, 1986. This device falls under the Dental review panel. Regulated under 21 CFR 872.4475.

Submission Details

510(k) Number	K864732 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 1986
Decision Date	April 15, 1987
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—