SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS


Device Classification Name

neurological stereotaxic instrument

510(k) Number K021815
Device Name SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
Original Applicant
SMITH & NEPHEW, INC.
1450 e brooks road
memphis, 
TN 
38116

Original Contact gino j rouss
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 06/03/2002
Decision Date 10/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No