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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pin, fixation, smooth
510(k) Number K061607
Device Name STORM OPERATING KIT, MODEL 1-10-0
Applicant
INTELLIGENT ORTHOPAEDICS LTD
BRIERFIELD MILL
brierfield, nelson,  GB bb9 5nj
Applicant Contact neil mc lachlan
Correspondent
INTELLIGENT ORTHOPAEDICS LTD
BRIERFIELD MILL
brierfield, nelson,  GB bb9 5nj
Correspondent Contact neil mc lachlan
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
HWC  
Date Received06/09/2006
Decision Date 07/18/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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