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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 K050535
Device Name STRYKER MMF SCREW
Applicant
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact NATHAN M MIERSMA
Correspondent
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact NATHAN M MIERSMA
Regulation Number872.4880
Classification Product Code
DZL  
Date Received03/02/2005
Decision Date 03/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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