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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone cement
510(K) Number K014199
Device Name SURGICAL SIMPLEX P WITH TOBRAMYCIN
Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale,  NJ  07401 1677
Contact william j cymbaluk
Regulation Number888.3027
Classification Product Code
LOD  
Date Received12/21/2001
Decision Date 05/06/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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