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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 K943856
Device Name FIXATION PINS/WIRES
Applicant
Acu Med, Inc.
10950 SW 5th St.
Suite 170
Beaverton,  OR  97005
Applicant Contact SHARI L JEFFERS
Correspondent
Acu Med, Inc.
10950 SW 5th St.
Suite 170
Beaverton,  OR  97005
Correspondent Contact SHARI L JEFFERS
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
JDW  
Date Received08/08/1994
Decision Date 07/06/1995
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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