FDA · official record K962017Substantially Equivalent

HYPODERMIC JET INJECTION APPARATUS

Name: HYPODERMIC JET INJECTION APPARATUS — FDA K962017
Creator: American Jet Injector Corp.
Keywords: HYPODERMIC JET INJECTION APPARATUS, HYPODERMIC JET INJECTION APPARATUS, K962017, EGM, FDA

United StatesEGMAmerican Jet Injector Corp.

Verified

Official record identity

FDA application number: K962017
Decision date: July 26, 1996
Published decision: Substantially Equivalent

Classification

Product code: EGM

Published parties

Applicant: American Jet Injector Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-05-23
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4475

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.