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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthopedic computer controlled surgical system
510(k) Number K072629
Device Name DIGIMATCH ROBODOC SURGICAL SYSTEM
Original Applicant
INTEGRATED SURGICAL SYSTEMS, INC.
1433 n. market blvd., #1
sacremento,  CA  95834
Original Contact russ hibbert
Regulation Number882.4560
Classification Product Code
OJP  
Subsequent Product Code
HAW  
Date Received09/17/2007
Decision Date 08/06/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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