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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wrap, sterilization
510(k) Number K113776
Model 9020,9030,9040,9050
Device Name FLASHPAK
Original Applicant
61 john vertente blvd
new bedford,  MA  02745
Original Contact robert johnson
Regulation Number880.6850
Classification Product Code
Date Received12/22/2011
Decision Date 08/08/2012
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