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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 K974487
Device Name SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020
Applicant
ASI MEDICAL, INC.
14550 EAST EASTER AVE.
SUITE 700
ENGLEWOOD,  CO  80112
Applicant Contact JOHN W MCPEEK
Correspondent
ASI MEDICAL, INC.
14550 EAST EASTER AVE.
SUITE 700
ENGLEWOOD,  CO  80112
Correspondent Contact JOHN W MCPEEK
Regulation Number872.6640
Classification Product Code
EIA  
Date Received11/26/1997
Decision Date 02/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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