FDA · official record K033822Substantially Equivalent

RESPIRONICS CUSTOM I ORAL APPLIANCE

Name: RESPIRONICS CUSTOM I ORAL APPLIANCE — FDA K033822
Creator: Respironics, Inc.
Keywords: RESPIRONICS CUSTOM I ORAL APPLIANCE, RESPIRONICS CUSTOM I ORAL APPLIANCE, K033822, LRK, FDA

United StatesLRKRespironics, Inc.

Verified

Official record identity

FDA application number: K033822
Decision date: February 06, 2004
Published decision: Substantially Equivalent

Classification

Product code: LRK

Published parties

Applicant: Respironics, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2003-12-10
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.5570

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.