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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name sterilization wrap containers, trays, cassettes & other accessories
510(k) Number K121280
Device Name MYOSURE INTRUMENT TRAY
Original Applicant
HOLOGIC, INC.
250 campus drive
marlborough,  MA  01752
Original Contact daniel f phelan
Regulation Number880.6850
Classification Product Code
KCT  
Date Received04/30/2012
Decision Date 02/08/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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