FDA · official record K060388Substantially Equivalent

TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT

Name: TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT — FDA K060388
Creator: Airway Management, Inc.
Keywords: TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT, TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT, K060388, LRK, FDA

United StatesLRKAirway Management, Inc.

Verified

Official record identity

FDA application number: K060388
Decision date: May 17, 2006
Published decision: Substantially Equivalent

Classification

Product code: LRK

Published parties

Applicant: Airway Management, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2006-02-14
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.