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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 K934779
Device Name AGRAM SPYRAL ELECTRODE
Applicant
Agram Export-Import Co.
44 Fairview Ave.
Glen Rock,  NJ  07452
Applicant Contact GORAN KOMARICA
Correspondent
Agram Export-Import Co.
44 Fairview Ave.
Glen Rock,  NJ  07452
Correspondent Contact GORAN KOMARICA
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received10/06/1993
Decision Date 03/14/1995
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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