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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Alterable
510(k) Number K861884
Device Name NEUROSCOPE SEEG
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 Number882.5320
Classification Product Code
GWO  
Date Received05/15/1986
Decision Date 10/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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