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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, Non-Alterable
510(k) Number K971252
Device Name SEVRAIN CRANIAL CLAMP
Applicant
IKONOS CORP.
320 S.W. 6TH. AVE., 2ND. FL.
PORTLAND,  OR  97204
Applicant Contact CHARLES ALBERT
Correspondent
IKONOS CORP.
320 S.W. 6TH. AVE., 2ND. FL.
PORTLAND,  OR  97204
Correspondent Contact CHARLES ALBERT
Regulation Number882.5330
Classification Product Code
GXN  
Date Received04/03/1997
Decision Date 07/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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