FDA · official record K110392Substantially Equivalent

PSM LOMAS / BENEFIT SCREWS

Name: PSM LOMAS / BENEFIT SCREWS — FDA K110392
Creator: Psm Medical Solutions
Keywords: PSM LOMAS / BENEFIT SCREWS, PSM LOMAS / BENEFIT SCREWS, K110392, OAT, FDA

United StatesOATPsm Medical Solutions

Verified

Official record identity

FDA application number: K110392
Decision date: December 14, 2011
Published decision: Substantially Equivalent

Classification

Product code: OAT

Published parties

Applicant: Psm Medical Solutions

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2011-02-11
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3640

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.