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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. N.W.
WASHINGTON,  DC  20005
Applicant Contact RICHARD D MANTHEI
Correspondent
MCKENNA & CUNEO
1575 EYE ST. N.W.
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
Recalls CDRH Recalls
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