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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Lesion, Radiofrequency
510(k) Number K070336
Device Name STOCKERT NEURO N50, MODEL12267
Applicant
STOCKERT GMBH
BOETZINGER STRASSE 72
FREIBURG, B-W,  DE D-79111
Applicant Contact DOMINIKA SCHULER
Correspondent
STOCKERT GMBH
BOETZINGER STRASSE 72
FREIBURG, B-W,  DE D-79111
Correspondent Contact DOMINIKA SCHULER
Regulation Number882.4400
Classification Product Code
GXD  
Date Received02/05/2007
Decision Date 06/14/2007
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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