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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, operative dental
510(k) Number K110481
Device Name TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
Applicant
ASI MEDICAL, INC.
14550 E EASTER AVE.
SUITE 700
CENTENNIAL,  CO  80112
Applicant Contact JOHN MCPEEK
Correspondent
ASI MEDICAL, INC.
14550 E EASTER AVE.
SUITE 700
CENTENNIAL,  CO  80112
Correspondent Contact JOHN MCPEEK
Regulation Number872.6640
Classification Product Code
EIA  
Date Received02/18/2011
Decision Date 04/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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