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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name probe, radiofrequency lesion
510(k) Number K011387
Device Name NEUROTHERM, MODEL JK4
Applicant
EUROLINK LLC.
77 LOCKSLEY RD.
LYNNFIELD,  MA  01940
Applicant Contact WILLIAM RITTMAN
Correspondent
EUROLINK LLC.
77 LOCKSLEY RD.
LYNNFIELD,  MA  01940
Correspondent Contact WILLIAM RITTMAN
Regulation Number882.4725
Classification Product Code
GXI  
Date Received05/07/2001
Decision Date 09/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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