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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K050606
Device Name SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
Applicant
Synthes (Usa)
1302 Wrights Lane E.
West Chester,  PA  19380
Applicant Contact KATHY ANDERSON
Correspondent
Synthes (Usa)
1302 Wrights Lane E.
West Chester,  PA  19380
Correspondent Contact KATHY ANDERSON
Regulation Number872.4880
Classification Product Code
DZL  
Date Received03/10/2005
Decision Date 04/06/2005
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
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