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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airbrush
510(k) Number K974488
Device Name AIRPREP SYSTEM - MODEL 9001
Applicant
Asi Medical, Inc.
14550 E Easter Ave.
Suite 700
Centennial,  CO  80112
Applicant Contact JOHN W MCPEEK
Correspondent
Asi Medical, Inc.
14550 E Easter Ave.
Suite 700
Centennial,  CO  80112
Correspondent Contact JOHN W MCPEEK
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received11/26/1997
Decision Date 05/26/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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