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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 K010499
Device Name SYNTHES (USA) MIDFACE DISTRACTOR
Applicant
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Applicant Contact THOMAS M MAGUIRE
Correspondent
SYNTHES (USA)
1690 RUSSELL RD.
PAOLI,  PA  19301
Correspondent Contact THOMAS M MAGUIRE
Regulation Number872.4760
Classification Product Code
JEY  
Date Received02/21/2001
Decision Date 05/03/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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