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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 K992000
Device Name SYNTHES CRANIAL FLAP TUBE CLAMP
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
P.O. BOX 1766
PAOLI,  PA  19301
Applicant Contact SHERI L MUSGNUNG
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
P.O. BOX 1766
PAOLI,  PA  19301
Correspondent Contact SHERI L MUSGNUNG
Regulation Number882.5330
Classification Product Code
GXN  
Date Received06/15/1999
Decision Date 07/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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