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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 K063790
Device Name THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
Applicant
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Applicant Contact DEBORAH L JACKSON
Correspondent
SYNTHES (USA)
1301 GOSHEN PKWY
WEST CHESTER,  PA  19380
Correspondent Contact DEBORAH L JACKSON
Regulation Number872.4760
Classification Product Code
JEY  
Date Received12/22/2006
Decision Date 04/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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