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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 K013120
Device Name PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18
Applicant
MEDAMICUS, INC.
15301 HWY. 55 WEST
MINNEAPOLIS,  MN  55447
Applicant Contact DENNIS S MADISON
Correspondent
MEDAMICUS, INC.
15301 HWY. 55 WEST
MINNEAPOLIS,  MN  55447
Correspondent Contact DENNIS S MADISON
Regulation Number882.5880
Classification Product Code
GZB  
Date Received09/18/2001
Decision Date 01/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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