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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 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 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
Predetermined Change
Control Plan Authorized		 No
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