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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 K993239
Device Name STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
Applicant
Stryker Corp.
4100 E. Milham Ave.
Kalamazoo,  MI  49001 -6197
Applicant Contact NICOLE PETTY
Correspondent
Stryker Corp.
4100 E. Milham Ave.
Kalamazoo,  MI  49001 -6197
Correspondent Contact NICOLE PETTY
Regulation Number882.4560
Classification Product Code
HAW  
Date Received09/27/1999
Decision Date 01/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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