FDA · official record K896219Substantially Equivalent

SAFE-T-CAP NEEDLE COVER

Name: SAFE-T-CAP NEEDLE COVER — FDA K896219
Creator: Ausmedics Pty , Ltd.
Keywords: SAFE-T-CAP NEEDLE COVER, SAFE-T-CAP NEEDLE COVER, K896219, DZM, FDA

United StatesDZMAusmedics Pty , Ltd.

Verified

Official record identity

FDA application number: K896219
Decision date: January 22, 1990
Published decision: Substantially Equivalent

Classification

Product code: DZM

Published parties

Applicant: Ausmedics Pty , Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1989-10-27
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4730

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.