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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 K943540
Device Name SURGICAL CUTTING BURS
Applicant
STRYKER CORP.
4100 E MILHAM AVE.
PORTAGE,  MI  49002 -9704
Applicant Contact TAMMY LOUNDS
Correspondent
STRYKER CORP.
4100 E MILHAM AVE.
PORTAGE,  MI  49002 -9704
Correspondent Contact TAMMY LOUNDS
Regulation Number872.4120
Classification Product Code
DZJ  
Date Received07/22/1994
Decision Date 11/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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