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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 K921748
Device Name MODEL 2000 DENTAL AIR ABRASIVE SYSTEM
Applicant
Texas Airsonics, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact CYNTHIA A SINCLAIR
Correspondent
Texas Airsonics, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact CYNTHIA A SINCLAIR
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received04/13/1992
Decision Date 11/25/1992
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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