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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
Predetermined Change
Control Plan Authorized		 No
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