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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 K091233
Device Name SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES
Applicant
Synthes (Usa)
1301 Goshen Pkwy.
West Chester,  PA  19380
Applicant Contact ANDREA M TASKER
Correspondent
Synthes (Usa)
1301 Goshen Pkwy.
West Chester,  PA  19380
Correspondent Contact ANDREA M TASKER
Regulation Number872.4760
Classification Product Code
JEY  
Date Received04/27/2009
Decision Date 12/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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