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FDA 510(k) Application Details - K110481
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K110481
Device Name
Unit, Operative Dental
Applicant
ASI MEDICAL, INC.
14550 E EASTER AVE.
SUITE 700
CENTENNIAL, CO 80112 US
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Contact
JOHN MCPEEK
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/18/2011
Decision Date
04/05/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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