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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Spinal Epidural
510(k) Number K110609
Device Name EPIDUCER LEAD DELIVERY SYSTEM
Applicant
St Jude Medical
6901 Preston Rd.
Plano,  TX  75024
Applicant Contact RASHMI MOZA
Correspondent
St Jude Medical
6901 Preston Rd.
Plano,  TX  75024
Correspondent Contact RASHMI MOZA
Regulation Number882.5880
Classification Product Code
LHG  
Subsequent Product Code
GZB  
Date Received03/03/2011
Decision Date 06/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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