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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
Applicant
SYNTHES INC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact ALAN T HALEY
Correspondent
SYNTHES INC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact ALAN T HALEY
Regulation Number872.4760
Classification Product Code
MQN  
Date Received05/21/2012
Decision Date 08/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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