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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
Recalls CDRH Recalls
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