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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 K961497
Device Name PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM
Original Applicant
HOWMEDICA, INC.
359 veterans blvd.
rutherford,  NJ  07070 -2584
Original Contact john dichiara
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/18/1996
Decision Date 06/28/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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