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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 K781311
Device Name ELECTRODE, NEEDLE, CFM
Applicant
APPLIED MEDICAL RESEARCH
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
APPLIED MEDICAL RESEARCH
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received07/31/1978
Decision Date 08/21/1978
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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