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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K032925
Device Name B&R DEVICE
Applicant
Ronvig A/S
Gl. Vejlevej 57-59
Daugaard,  DK 8721
Applicant Contact ANNETTE RAVN NIELSEN
Correspondent
Ronvig A/S
Gl. Vejlevej 57-59
Daugaard,  DK 8721
Correspondent Contact ANNETTE RAVN NIELSEN
Regulation Number872.4200
Classification Product Code
EGS  
Subsequent Product Code
CFR  
Date Received09/22/2003
Decision Date 12/22/2003
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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