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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 K010008
Device Name AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX
Applicant
Micronet Medical, Inc.
1839 Buerkle Rd.
White Bear Lake,,  MN  55110
Applicant Contact CHARLES LEHMAN
Correspondent
Micronet Medical, Inc.
1839 Buerkle Rd.
White Bear Lake,,  MN  55110
Correspondent Contact CHARLES LEHMAN
Regulation Number882.5880
Classification Product Code
GZB  
Date Received01/02/2001
Decision Date 07/16/2001
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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