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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 DRIVE
LUTZ,  FL  33559
Applicant Contact CHARLES C BERKINS
Correspondent
ROCHESTER ELECTRO MEDICAL, INC.
4212 CYPRESS GULCH DRIVE
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
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