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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 K070134
Device Name MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098
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 Received01/16/2007
Decision Date 03/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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