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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
Original Applicant
SYNTHES INC
1301 goshen parkway
west chester,  PA  19380
Original Contact alan t haley
Regulation Number872.4760
Classification Product Code
JEY  
Date Received08/30/2012
Decision Date 02/28/2013
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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