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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 K991784
Device Name RENEW LEAD EXTENSION
Applicant
ADVANCED NEUROMODULATION SYSTEMS
ONE ALLENTOWN PKWY.
ALLEN,  TX  75002
Applicant Contact KATRYNA WARREN
Correspondent
ADVANCED NEUROMODULATION SYSTEMS
ONE ALLENTOWN PKWY.
ALLEN,  TX  75002
Correspondent Contact KATRYNA WARREN
Regulation Number882.5880
Classification Product Code
GZB  
Date Received05/25/1999
Decision Date 06/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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