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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
Applicant
Hilla Technologies, Inc.
7046 Owl'S Nest Ter.
Bradenton,  FL  34203
Applicant Contact CAROLYN M PRIMUS
Correspondent
Hilla Technologies, Inc.
7046 Owl'S Nest Ter.
Bradenton,  FL  34203
Correspondent Contact CAROLYN M PRIMUS
Regulation Number872.6660
Classification Product Code
EIH  
Date Received12/02/2011
Decision Date 03/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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