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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 K062789
FOIA Releasable 510(k) K062789
Device Name SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
Applicant
SYNTHES (USA)
1230 WILSON DRIVE
WEST CHESTER,  PA  19380
Applicant Contact JEFFREY DOW
Correspondent
SYNTHES (USA)
1230 WILSON DRIVE
WEST CHESTER,  PA  19380
Correspondent Contact JEFFREY DOW
Regulation Number872.4760
Classification Product Code
JEY  
Date Received09/18/2006
Decision Date 02/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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