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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powder, porcelain
510(k) Number K113575
Device Name HILLA DIGITAL TRANSFERS
Original Applicant
HILLA TECHNOLOGIES, INC.
7046 owl's nest terrace
bradenton,  FL  34203
Original Contact carolyn m primus
Regulation Number872.6660
Classification Product Code
EIH  
Date Received12/02/2011
Decision Date 03/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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