FDA · official record K014001Substantially Equivalent

DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3

Name: DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 — FDA K014001
Creator: Oral Osteodistraction, L.P.
Keywords: DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3, DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3, K014001, MQN, FDA

United StatesMQNOral Osteodistraction, L.P.

Verified

Official record identity

FDA application number: K014001
Decision date: February 04, 2003
Published decision: Substantially Equivalent

Classification

Product code: MQN

Published parties

Applicant: Oral Osteodistraction, L.P.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2001-12-04
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.