FDA · official record K904948Substantially Equivalent

PM2002 CC AND PM2002 EC

Name: PM2002 CC AND PM2002 EC — FDA K904948
Creator: Planmeca USA, Inc.
Keywords: PM2002 CC AND PM2002 EC, PM2002 CC AND PM2002 EC, K904948, EIA, FDA

United StatesEIAPlanmeca USA, Inc.

Verified

Official record identity

FDA application number: K904948
Decision date: January 30, 1991
Published decision: Substantially Equivalent

Classification

Product code: EIA

Published parties

Applicant: Planmeca USA, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1990-11-01
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.