FDA · official record K000967Substantially Equivalent

4635 ASSISTANT'S INSTRUMENTATION

Name: 4635 ASSISTANT'S INSTRUMENTATION — FDA K000967
Creator: A-Dec, Inc.
Keywords: 4635 ASSISTANT'S INSTRUMENTATION, 4635 ASSISTANT'S INSTRUMENTATION, K000967, EIA, FDA

United StatesEIAA-Dec, Inc.

Verified

Official record identity

FDA application number: K000967
Decision date: May 03, 2000
Published decision: Substantially Equivalent

Classification

Product code: EIA

Published parties

Applicant: A-Dec, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2000-03-27
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6640

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.