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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 K050608
Device Name SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM
Applicant
Synthes (Usa)
1302 Wrights Lane E.
West Chester,  PA  19380
Applicant Contact SHERI L MUSGNUNG
Correspondent
Synthes (Usa)
1302 Wrights Lane E.
West Chester,  PA  19380
Correspondent Contact SHERI L MUSGNUNG
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
DZL  
Date Received03/10/2005
Decision Date 05/18/2005
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
Recalls CDRH Recalls
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