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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Photic, Evoked Response
510(k) Number K023525
Device Name RETISCAN, RETIPORT
Applicant
ROLAND CONSULT
FRIEDRICH-FRANZ-STRASSE 19
BRANDENBURG,  DE D 14770
Applicant Contact MATTHIAS MAI
Correspondent
ROLAND CONSULT
FRIEDRICH-FRANZ-STRASSE 19
BRANDENBURG,  DE D 14770
Correspondent Contact MATTHIAS MAI
Regulation Number882.1890
Classification Product Code
GWE  
Date Received10/21/2002
Decision Date 03/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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