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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K010204
FOIA Releasable 510(k) K010204
Device Name STRYKER NAVIGATION SYSTEM-KNEE MODULE
Applicant
STRYKER CORP.
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001 -6197
Applicant Contact NICOLE PETTY
Correspondent
STRYKER CORP.
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001 -6197
Correspondent Contact NICOLE PETTY
Regulation Number882.4560
Classification Product Code
HAW  
Date Received01/23/2001
Decision Date 08/31/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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