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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 K092371
Device Name SWIFT-LOCK ANCHOR, MODEL 1192
Applicant
ADVANCED NEUROMODULATION SYSTEMS
6901 PRESTON RD.
PLANO,  TX  75024
Applicant Contact PENNY HOUSTON
Correspondent
ADVANCED NEUROMODULATION SYSTEMS
6901 PRESTON RD.
PLANO,  TX  75024
Correspondent Contact PENNY HOUSTON
Regulation Number882.5880
Classification Product Code
GZB  
Date Received08/05/2009
Decision Date 12/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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