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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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More FDA Info for this Product Code
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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