PIGALILEO 4TH GENERATION SYSTEM


Device Classification Name

neurological stereotaxic instrument

510(k) Number K080875
Device Name PIGALILEO 4TH GENERATION SYSTEM
Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Applicant Contact rishi sinha
Correspondent
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Correspodent Contact rishi sinha
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 03/31/2008
Decision Date 07/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No