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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 K932873
Device Name SEAC MOBILE UNIT BY ASI MEDICAL
Applicant
ASI MEDICAL, INC.
14550 EAST EASTER AVE.
SUITE 700
ENGLEWOOD,  CO  80112
Applicant Contact JOHN MCPEEK
Correspondent
ASI MEDICAL, INC.
14550 EAST EASTER AVE.
SUITE 700
ENGLEWOOD,  CO  80112
Correspondent Contact JOHN MCPEEK
Regulation Number872.6640
Classification Product Code
EIA  
Date Received06/14/1993
Decision Date 03/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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