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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, Threaded
510(k) Number K932349
Device Name ORTHOPEDIC THREADED PIN FIXATION
Applicant
Osteomed Corp.
2753 Freeman St.
Fort Wayne,  IN  46802
Applicant Contact BILLY DARMAWAN
Correspondent
Osteomed Corp.
2753 Freeman St.
Fort Wayne,  IN  46802
Correspondent Contact BILLY DARMAWAN
Regulation Number888.3040
Classification Product Code
JDW  
Date Received05/14/1993
Decision Date 03/01/1994
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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