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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Battery-Powered
510(k) Number K061983
Device Name STIMUPLEX PEN
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 Number868.2775
Classification Product Code
BXN  
Date Received07/13/2006
Decision Date 11/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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