FDA · official record K014263Substantially Equivalent

NEWGEN/UNIVERSAL MANDIBULAR SYSTEM

Name: NEWGEN/UNIVERSAL MANDIBULAR SYSTEM — FDA K014263
Creator: Stryker Instruments
Keywords: NEWGEN/UNIVERSAL MANDIBULAR SYSTEM, NEWGEN/UNIVERSAL MANDIBULAR SYSTEM, K014263, JEY, FDA

United StatesJEYStryker Instruments

Verified

Official record identity

FDA application number: K014263
Decision date: March 08, 2002
Published decision: Substantially Equivalent

Classification

Product code: JEY

Published parties

Applicant: Stryker Instruments

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2001-12-27
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4760

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.