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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 K955335
Device Name DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING 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 Received11/20/1995
Decision Date 01/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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