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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement
510(k) Number K032945
Device Name SIMPLEX X
Applicant
STRYKER CORP.
4100 E. MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact DANNIELLE WHEELER
Correspondent
STRYKER CORP.
4100 E. MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact DANNIELLE WHEELER
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
NDN  
Date Received09/22/2003
Decision Date 05/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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