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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 Avenue
Somerset,  MA  02726
Applicant Contact GEORGE J HATTUB
Correspondent
MEDOC LTD. ADVANCED MEDICAL SYSTEMS
291 Hillside Avenue
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
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