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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name external mandibular fixator and/or distractor
510(k) Number K121502
Device Name SYNTHES CURVILINEAR DISTRACTION SYSTEM
Original Applicant
SYNTHES INC
1301 goshen parkway
west chester,  PA  19380
Original Contact alan t haley
Regulation Number872.4760
Classification Product Code
MQN  
Date Received05/21/2012
Decision Date 08/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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