FDA · official record K962445Substantially Equivalent

ARTHROCARE DENTAL ELECTROSURGERY SYSTEM

Name: ARTHROCARE DENTAL ELECTROSURGERY SYSTEM — FDA K962445
Creator: Arthrocare Corp.
Keywords: ARTHROCARE DENTAL ELECTROSURGERY SYSTEM, ARTHROCARE DENTAL ELECTROSURGERY SYSTEM, K962445, EKZ, FDA

United StatesEKZArthrocare Corp.

Verified

Official record identity

FDA application number: K962445
Decision date: July 30, 1996
Published decision: Substantially Equivalent

Classification

Product code: EKZ

Published parties

Applicant: Arthrocare Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-06-24
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.4920

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.