FDA · official record K962527Substantially Equivalent

GENERAL PURPOSE DENTAL TRAY

Name: GENERAL PURPOSE DENTAL TRAY — FDA K962527
Creator: Medcare Medical Group, Inc.
Keywords: GENERAL PURPOSE DENTAL TRAY, GENERAL PURPOSE DENTAL TRAY, K962527, EIA, FDA

United StatesEIAMedcare Medical Group, Inc.

Verified

Official record identity

FDA application number: K962527
Decision date: August 01, 1996
Published decision: Substantially Equivalent

Classification

Product code: EIA

Published parties

Applicant: Medcare Medical Group, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-06-27
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.