Cleared Traditional

HYPODERMIC JET INJECTION APPARATUS

K962017 · American Jet Injector Corp. · Dental

Jul 1996

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K962017 is an FDA 510(k) clearance for the HYPODERMIC JET INJECTION APPARATUS, a Injector, Jet, Mechanical-powered (Class II — Special Controls, product code EGM), submitted by American Jet Injector Corp. (Lansdale, US). The FDA issued a Cleared decision on July 26, 1996, 64 days after receiving the submission on May 23, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.4475.

Submission Details

510(k) Number	K962017 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 1996
Decision Date	July 26, 1996
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement