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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K021118
Device Name DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570
Applicant
Class A Ent.
P.O. Box 401964-16039
Suite C
Hesperia,  CA  92345
Applicant Contact SAMANTHA L DRAPER
Correspondent
Class A Ent.
P.O. Box 401964-16039
Suite C
Hesperia,  CA  92345
Correspondent Contact SAMANTHA L DRAPER
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received04/08/2002
Decision Date 05/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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