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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, auditory, evoked response
510(k) Number K852687
Device Name ALGO I
Applicant
ALGOTEK, INC.
805 VETERANS BLVD.
REDWOOD CITY,  CA  94063
Applicant Contact LIVERANI
Correspondent
ALGOTEK, INC.
805 VETERANS BLVD.
REDWOOD CITY,  CA  94063
Correspondent Contact LIVERANI
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received06/25/1985
Decision Date 09/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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