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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 K862430
Device Name SIEGEN HEADPHONES
Applicant
SIEGEN CORP.
2400 BAYSHORE FRONTAGE RD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact BERT MYERS
Correspondent
SIEGEN CORP.
2400 BAYSHORE FRONTAGE RD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact BERT MYERS
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received06/26/1986
Decision Date 09/26/1986
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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