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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K944547
Device Name DANTEC KEYPOINT
Applicant
Mckenna & Cuneo
1575 Eye St. NW
Washington,  DC  20005
Applicant Contact RICHARD D MANTHEI
Correspondent
Mckenna & Cuneo
1575 Eye St. NW
Washington,  DC  20005
Correspondent Contact RICHARD D MANTHEI
Regulation Number882.1870
Classification Product Code
GWF  
Date Received09/15/1994
Decision Date 09/19/1995
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
Recalls CDRH Recalls
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