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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K032117
Device Name STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
Applicant
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact JEAN W SHEPPARD
Correspondent
Stryker Instruments
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact JEAN W SHEPPARD
Regulation Number872.4120
Classification Product Code
DZI  
Subsequent Product Codes
EIA   ERL   GEY   HBC   HBE  
HSZ  
Date Received07/09/2003
Decision Date 08/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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