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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name arthroscope
510(k) Number K121893
Device Name STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM
Original Applicant
STRYKER ENDOSCOPY
5900 optical ct.
san jose,  CA  95138
Original Contact lifei liu
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
KOG  
Date Received06/29/2012
Decision Date 09/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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