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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K040594
Device Name HERCULON SOFT TISSUE REATTACHMENT SYSTEM
Original Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 glover ave.
norwalk,  CT  06856
Original Contact chester mccoy
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/08/2004
Decision Date 03/31/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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