FDA · official record K083209Substantially Equivalent

ACRYLIC HERBST SPLINT APPLIANCE

Name: ACRYLIC HERBST SPLINT APPLIANCE — FDA K083209
Creator: Specialty Appliance Works, Inc.
Keywords: ACRYLIC HERBST SPLINT APPLIANCE, ACRYLIC HERBST SPLINT APPLIANCE, K083209, LRK, FDA

United StatesLRKSpecialty Appliance Works, Inc.

Verified

Official record identity

FDA application number: K083209
Decision date: January 27, 2009
Published decision: Substantially Equivalent

Classification

Product code: LRK

Published parties

Applicant: Specialty Appliance Works, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2008-10-31
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.