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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 K080914
Device Name ULTRASHARP CONCENTRIC NEEDLES
Applicant
Rochester Electro Medical, Inc.
4212 Cypress Gulch Dr.
Lutz,  FL  33559
Applicant Contact CHARLES C BERKINS
Correspondent
Rochester Electro Medical, Inc.
4212 Cypress Gulch Dr.
Lutz,  FL  33559
Correspondent Contact CHARLES C BERKINS
Regulation Number890.1385
Classification Product Code
IKT  
Date Received04/01/2008
Decision Date 07/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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