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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K103400
Device Name FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP
Applicant
Stryker Corporation
Boetzinger St. 41
Freiburg, Baden-Wuerttemberg,  DE 79111
Applicant Contact LILIAN ECKERT
Correspondent
Stryker Corporation
Boetzinger St. 41
Freiburg, Baden-Wuerttemberg,  DE 79111
Correspondent Contact LILIAN ECKERT
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
LLZ  
Date Received11/19/2010
Decision Date 03/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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