GLOBUS GENESY 1100 STIMULATOR

Device Classification Name

stimulator, muscle, powered

510(k) Number K071431
Device Name GLOBUS GENESY 1100 STIMULATOR
Applicant
DOMINO S.R.L.
18 eustace drive
west hartford, 
CT 
06110

Applicant Contact giovanni m ciriani
Correspondent
DOMINO S.R.L.
18 eustace drive
west hartford, 
CT 
06110

Correspodent Contact giovanni m ciriani
Regulation Number 890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   LIH  
Date Received 05/23/2007
Decision Date 09/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No