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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Dental
510(k) Number K882183
Device Name DENTAL BURS
Applicant
Tri-Stage, Inc.
5897 Oberlin Dr. #205
San Diego,  CA  92121
Applicant Contact ALAN DONALD
Correspondent
Tri-Stage, Inc.
5897 Oberlin Dr. #205
San Diego,  CA  92121
Correspondent Contact ALAN DONALD
Regulation Number872.3240
Classification Product Code
EJL  
Date Received05/24/1988
Decision Date 06/21/1988
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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