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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 K950115
Device Name LUHR(R) TITANIUM BURR HOLE COVERS
Applicant
HOWMEDICA, INC.
359 veterans blvd.
rutherford,  NJ  07070 2584
Contact john f dichiara
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/11/1995
Decision Date 04/10/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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