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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Driver, Wire, And Bone Drill, Manual
510(k) Number K150796
Device Name Dental Bone Cutting Instruments
Applicant
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
West Chester,  PA  19380
Applicant Contact SUSAN LEWANDOWSKI
Correspondent
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
West Chester,  PA  19380
Correspondent Contact SUSAN LEWANDOWSKI
Regulation Number872.4120
Classification Product Code
DZJ  
Date Received03/26/2015
Decision Date 06/23/2015
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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