FDA · official record K864732Substantially Equivalent

GRADTECH SYRINGE SYSTEM

Name: GRADTECH SYRINGE SYSTEM — FDA K864732
Creator: Gradtech
Keywords: GRADTECH SYRINGE SYSTEM, GRADTECH SYRINGE SYSTEM, K864732, EGM, FDA

United StatesEGMGradtech

Verified

Official record identity

FDA application number: K864732
Decision date: April 15, 1987
Published decision: Substantially Equivalent

Classification

Product code: EGM

Published parties

Applicant: Gradtech

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1986-12-04
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4475

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.