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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, bone
510(k) Number K042987
Device Name MODIFICATION TO SYNTHES CRANIAL PLATES
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Applicant Contact LISA M BOYLE
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Correspondent Contact LISA M BOYLE
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
GXR  
Date Received10/29/2004
Decision Date 11/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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