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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 K111573
Model MONOBLOC BM C5, C8, C10, C12, C14
Device Name MONOBLOC BM SERIES
Original Applicant
HASS CORP.
951 starbuck st.
unit j
fullerton,  CA  92833
Original Contact priscilla chung
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/06/2011
Decision Date 08/26/2011
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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