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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 K142292
Device Name Speed, Speed Shift, Speed Titan, Speed Arc
Applicant
BioMedical Enterprises, Inc.
14785 Omicron Dr.,
Suite 205
San Antonio,  TX  78245
Applicant Contact Joe Soward
Correspondent
BioMedical Enterprises, Inc.
14785 Omicron Dr.,
Suite 205
San Antonio,  TX  78245
Correspondent Contact Joe Soward
Regulation Number888.3030
Classification Product Code
JDR  
Date Received08/18/2014
Decision Date 11/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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