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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 K033065
Device Name SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Applicant Contact BONNIE SMITH
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Correspondent Contact BONNIE SMITH
Regulation Number872.4760
Classification Product Code
MQN  
Subsequent Product Code
JEY  
Date Received09/29/2003
Decision Date 10/29/2003
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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