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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K020400
Device Name DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
Applicant
Meps, LLC
One E. Broward Blvd. #700
Fort Lauderdale,  FL  33301
Applicant Contact HARRY BENEDICT
Correspondent
Meps, LLC
One E. Broward Blvd. #700
Fort Lauderdale,  FL  33301
Correspondent Contact HARRY BENEDICT
Regulation Number882.1870
Classification Product Code
GWF  
Date Received02/06/2002
Decision Date 08/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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