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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 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact JEAN W SHEPPARD
Correspondent
STRYKER INSTRUMENTS
4100 EAST 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
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