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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 K073307
Device Name MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM
Applicant
Bio-Technology USA, Inc.
1705 S. Capitol Of Texas Hwy.
Austin,  TX  78746
Applicant Contact IAN GORDON
Correspondent
Bio-Technology USA, Inc.
1705 S. Capitol Of Texas Hwy.
Austin,  TX  78746
Correspondent Contact IAN GORDON
Regulation Number872.4760
Classification Product Code
JEY  
Date Received11/23/2007
Decision Date 10/29/2008
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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