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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Evoked Potential Stimulator, Thermal
510(k) Number K051448
Device Name MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)
Applicant
Medoc Ltd. Advanced Medical Systems
291 Hillside Ave.
Somerset,  MA  02726
Applicant Contact GEORGE J HATTUB
Correspondent
Medoc Ltd. Advanced Medical Systems
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact GEORGE J HATTUB
Regulation Number882.1870
Classification Product Code
NTU  
Date Received06/02/2005
Decision Date 06/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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