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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(K) Number K070170
Device Name DALL-MILES SYSTEM
Applicant
STRYKER ORTHOPAEDICS
325 corporate drive
mahwah,  NJ  07430
Contact patricia setti-laperch
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
JDQ   LYT  
Date Received01/18/2007
Decision Date 03/02/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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