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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 K012380
Device Name MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
Applicant
STRYKER LEIBINGER
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Applicant Contact ROBIN L ROWE
Correspondent
STRYKER LEIBINGER
4100 EAST MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact ROBIN L ROWE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received07/26/2001
Decision Date 12/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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