DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE


Device Classification Name

neurological stereotaxic instrument

510(k) Number K030343
Device Name DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE
Original Applicant
GYRUS ENT L.L.C.
2925 appling rd.
bartlett, 
TN 
38133

Original Contact gregory sredin
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 02/03/2003
Decision Date 05/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No