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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 K004027
Device Name STRYKER REMOTE SURGICAL PLANNING SYSTEM
Applicant
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,,  MI  49001
Applicant Contact NICOLE PETTY
Correspondent
STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO,,  MI  49001
Correspondent Contact NICOLE PETTY
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/27/2000
Decision Date 01/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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