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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K082649
Device Name SYNTHES 90 DEGREE SCREWDRIVER
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 Number872.4120
Classification Product Code
DZI  
Subsequent Product Code
DZJ  
Date Received09/12/2008
Decision Date 04/30/2009
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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