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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 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact ROBIN L ROWE
Correspondent
Stryker Leibinger
4100 E. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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