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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 K974206
Device Name SYNTHES CRANIAL SPRING CLIP (CSC)
Applicant
SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI,  PA  19301 -1222
Applicant Contact SHERI MUSGNUNG
Correspondent
SYNTHES (USA)
P.O. BOX 1766
1690 RUSSELL ROAD
PAOLI,  PA  19301 -1222
Correspondent Contact SHERI MUSGNUNG
Regulation Number882.5320
Classification Product Code
GWO  
Subsequent Product Code
HBW  
Date Received11/10/1997
Decision Date 03/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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