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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 K062299
Device Name SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT
Applicant
Synthes (Usa)
1301 Goshen Pkwy.
West Chester,  PA  19380
Applicant Contact SHERI L MUSGNUNG
Correspondent
Synthes (Usa)
1301 Goshen Pkwy.
West Chester,  PA  19380
Correspondent Contact SHERI L MUSGNUNG
Regulation Number872.4760
Classification Product Code
MQN  
Date Received08/08/2006
Decision Date 08/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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