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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cerclage, fixation
510(k) Number K121541
Device Name JAZZ SYSTEM
Original Applicant
IMPLANET S.A.
1835 market st.
29th floor
philadelphia,  PA  19103
Original Contact janice m hogan
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received05/24/2012
Decision Date 09/13/2012
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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