FDA 510(k) Application Details - K052357

Device Classification Name Evoked Potential Stimulator, Thermal

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510(K) Number K052357
Device Name Evoked Potential Stimulator, Thermal
Applicant MEDOC LTD. ADVANCED MEDICAL SYSTEMS
291 Hillside Avenue
Somerset, MA 02726 US
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Contact GEORGE J HATTUB
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Regulation Number 882.1870

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Classification Product Code NTU
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Date Received 08/29/2005
Decision Date 01/19/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K052357


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