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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K932352
Device Name ORTHOPEDIC BONE PLATE
Original Applicant
OSTEOMED CORP.
2753 freeman st.
fort wayne,  IN  46802
Original Contact billy darmawan
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/14/1993
Decision Date 07/05/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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