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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 K911031
Device Name THE TRAMOND PIN
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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