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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 EAST LEIGH STREET
SUITE 206-5
RICHMOND,  VA  23219
Applicant Contact EMILY B ROSSITER
Correspondent
JOHN W. KING
800 EAST LEIGH STREET
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
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