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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, bone
510(K) Number K122647
Device Name SYNTHES PATIENT SPECIFIC PLATE
Applicant
SYNTHES INC
1301 goshen parkway
west chester,  PA  19380
Contact alan t haley
Regulation Number872.4760
Classification Product Code
JEY  
Date Received08/30/2012
Decision Date 02/28/2013
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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