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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
Predetermined Change
Control Plan Authorized		 No
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