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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 K073674
Device Name BONE FIXATION WIRE (KIRSCHNER WIRE)
Applicant
Signal Medical Corp.
400 Pyramid Dr.
Marysville,  MI  48040
Applicant Contact LOUIS A SERAFIN
Correspondent
Signal Medical Corp.
400 Pyramid Dr.
Marysville,  MI  48040
Correspondent Contact LOUIS A SERAFIN
Regulation Number888.3040
Classification Product Code
HTY  
Date Received12/28/2007
Decision Date 03/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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