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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K133844
Device Name SPEED TRIAD
Applicant
Biomedical Ent., Inc.
14785 Omicron Dr., Suite 205
San Antonio,  TX  78245
Applicant Contact JOE SOWARD
Correspondent
Biomedical Ent., Inc.
14785 Omicron Dr., Suite 205
San Antonio,  TX  78245
Correspondent Contact JOE SOWARD
Regulation Number888.3030
Classification Product Code
JDR  
Date Received12/18/2013
Decision Date 04/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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