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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 K994097
Device Name MEDAMICUS EPIDURAL INTRODUCER
Applicant
Medamicus, Inc.
15301 Hwy. 55 W.
Minneapolis,  MN  55447
Applicant Contact DENNIS MANSON
Correspondent
Medamicus, Inc.
15301 Hwy. 55 W.
Minneapolis,  MN  55447
Correspondent Contact DENNIS MANSON
Regulation Number882.5880
Classification Product Code
GZB  
Date Received12/03/1999
Decision Date 03/01/2000
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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