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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 K080542
Device Name DISTRAX
Applicant
John W. King
800 E. Leigh St.
Suite 206-5
Richmond,  VA  23219
Applicant Contact EMILY B ROSSITER
Correspondent
John W. King
800 E. Leigh St.
Suite 206-5
Richmond,  VA  23219
Correspondent Contact EMILY B ROSSITER
Regulation Number872.4760
Classification Product Code
MQN  
Date Received02/27/2008
Decision Date 12/15/2008
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
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