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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 K010816
Device Name DENTO-PREP PARTICLE MICROBLASTER
Applicant
Ronvig A/S
Gl Vejlevelj 57-59
Dk-8721 Daugaard,  DK DK-8721
Applicant Contact ANNETTE RAVN NIELSEN
Correspondent
Ronvig A/S
Gl Vejlevelj 57-59
Dk-8721 Daugaard,  DK DK-8721
Correspondent Contact ANNETTE RAVN NIELSEN
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received03/19/2001
Decision Date 05/10/2001
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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