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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 K982950
Device Name FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
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 Received08/21/1998
Decision Date 06/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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