FDA · official record K030790Substantially Equivalent

OSTEOMED ALVEOLAR DISTRACTION SYSTEM

Name: OSTEOMED ALVEOLAR DISTRACTION SYSTEM — FDA K030790
Creator: Osteomed LP
Keywords: OSTEOMED ALVEOLAR DISTRACTION SYSTEM, OSTEOMED ALVEOLAR DISTRACTION SYSTEM, K030790, MQN, FDA

United StatesMQNOsteomed LP

Verified

Official record identity

FDA application number: K030790
Decision date: September 10, 2003
Published decision: Substantially Equivalent

Classification

Product code: MQN

Published parties

Applicant: Osteomed LP

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2003-03-12
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.