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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 K912783
Device Name DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
Applicant
Class A Ent.
7607 Lucerne Vista
Yucca Valley,  CA  92284
Applicant Contact JANICE A.AUDI
Correspondent
Class A Ent.
7607 Lucerne Vista
Yucca Valley,  CA  92284
Correspondent Contact JANICE A.AUDI
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received06/24/1991
Decision Date 02/05/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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