FDA · official record K953273Substantially Equivalent

BIOPLATE RIGID FIXATION BONE PLATING SYSTEM

Name: BIOPLATE RIGID FIXATION BONE PLATING SYSTEM — FDA K953273
Creator: Biomedics
Keywords: BIOPLATE RIGID FIXATION BONE PLATING SYSTEM, BIOPLATE RIGID FIXATION BONE PLATING SYSTEM, K953273, JEY, FDA

United StatesJEYBiomedics

Verified

Official record identity

FDA application number: K953273
Decision date: September 29, 1995
Published decision: Substantially Equivalent

Classification

Product code: JEY

Published parties

Applicant: Biomedics

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1995-07-13
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.