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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Smooth
510(k) Number K960483
Device Name STEINMAN PIN
Applicant
American Medical Specialties, Inc.
6090-H Mcdonough Dr.
Norcross,  GA  30093
Applicant Contact ROGER EAGLEN
Correspondent
American Medical Specialties, Inc.
6090-H Mcdonough Dr.
Norcross,  GA  30093
Correspondent Contact ROGER EAGLEN
Regulation Number888.3040
Classification Product Code
HTY  
Date Received02/02/1996
Decision Date 04/09/1996
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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