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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 K911452
Device Name FIXATION PIN
Applicant
Simpex, Inc.
13775 SW Larch Pl., Suite 26
Beaverton,  OR  97005
Applicant Contact RICHARD GORSKI
Correspondent
Simpex, Inc.
13775 SW Larch Pl., Suite 26
Beaverton,  OR  97005
Correspondent Contact RICHARD GORSKI
Regulation Number888.3040
Classification Product Code
HTY  
Date Received04/03/1991
Decision Date 04/12/1991
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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