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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name generator, lesion, radiofrequency
510(k) Number K052878
Device Name NT-1000
Applicant
NEUROTHERM, INC.
2 DEBUSH AVE. BUILDING A2
MIDDLETON,  MA  01949
Applicant Contact WILLIAM RITTMAN
Correspondent
NEUROTHERM, INC.
2 DEBUSH AVE. BUILDING A2
MIDDLETON,  MA  01949
Correspondent Contact WILLIAM RITTMAN
Regulation Number882.4400
Classification Product Code
GXD  
Date Received10/12/2005
Decision Date 01/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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