FDA · official record K850344Substantially Equivalent

AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG

Name: AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG — FDA K850344
Creator: Midwest
Keywords: AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG, AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG, K850344, EGS, FDA

United StatesEGSMidwest

Verified

Official record identity

FDA application number: K850344
Decision date: March 25, 1985
Published decision: Substantially Equivalent

Classification

Product code: EGS

Published parties

Applicant: Midwest

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1985-01-28
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4200

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.