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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 K911026
Device Name STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION
Applicant
Sport Service, Inc.
Suite 120 Canal Sq.
1054 31st St., NW
Washington,  DC  20000
Applicant Contact J-P LACLAU
Correspondent
Sport Service, Inc.
Suite 120 Canal Sq.
1054 31st St., NW
Washington,  DC  20000
Correspondent Contact J-P LACLAU
Regulation Number888.3030
Classification Product Code
JDR  
Date Received03/01/1991
Decision Date 05/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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