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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name motor, drill, pneumatic
510(k) Number K041754
Device Name STRYKER MAESTRO SYSTEM
Applicant
STRYKER CORP.
4100 E. MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact NICOLE PETTY
Correspondent
STRYKER CORP.
4100 E. MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact NICOLE PETTY
Regulation Number882.4370
Classification Product Code
HBB  
Date Received06/29/2004
Decision Date 09/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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