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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 K072463
Device Name SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM
Applicant
SATYRNE MEDICAL
1909 GOLD AVE. SE # 1
ALBUQUERQUE,  NM  87106
Applicant Contact SCOTT LOVALD
Correspondent
SATYRNE MEDICAL
1909 GOLD AVE. SE # 1
ALBUQUERQUE,  NM  87106
Correspondent Contact SCOTT LOVALD
Regulation Number872.4760
Classification Product Code
JEY  
Date Received08/31/2007
Decision Date 11/29/2007
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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