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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, Diagnostic Electromyograph
510(k) Number K912283
Device Name DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
Applicant
CHALGREN ENTERPRISES, INC.
8021 CARMEL ST.
SUITE B
GILROY,  CA  95020
Applicant Contact RICHARD KAISER
Correspondent
CHALGREN ENTERPRISES, INC.
8021 CARMEL ST.
SUITE B
GILROY,  CA  95020
Correspondent Contact RICHARD KAISER
Regulation Number890.1385
Classification Product Code
IKT  
Date Received05/23/1991
Decision Date 03/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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