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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 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 Number882.4560
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
Predetermined Change
Control Plan Authorized		 No
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