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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 K010300
Device Name MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
Applicant
Medtronic Vascular
800 53rd Ave., NE
Minneapolis,,  MN  55421
Applicant Contact PAM SCHAUB
Correspondent
Medtronic Vascular
800 53rd Ave., NE
Minneapolis,,  MN  55421
Correspondent Contact PAM SCHAUB
Regulation Number882.5880
Classification Product Code
GZB  
Date Received02/01/2001
Decision Date 08/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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