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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K041953
Device Name VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
Applicant
Conmedcorp
525 French Rd.
Utica,  NY  13502
Applicant Contact IRA DUESLER
Correspondent
Conmedcorp
525 French Rd.
Utica,  NY  13502
Correspondent Contact IRA DUESLER
Regulation Number882.1320
Classification Product Code
GXY  
Date Received07/20/2004
Decision Date 08/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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