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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, spinal-cord, implanted (pain relief)
510(k) Number K112214
Device Name OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS
Applicant
ST. JUDE MEDICAL NEUROMODULATION
6901 PRESTON RD.
PLANO,  TX  75024
Applicant Contact PENNY HOUSTON
Correspondent
ST. JUDE MEDICAL NEUROMODULATION
6901 PRESTON RD.
PLANO,  TX  75024
Correspondent Contact PENNY HOUSTON
Regulation Number882.5880
Classification Product Code
GZB  
Date Received08/02/2011
Decision Date 11/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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