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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K092214
Device Name CHIROPRO L SYSTEM
Applicant
Bien-Air Dental, SA
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA J NOLTE
Correspondent
Bien-Air Dental, SA
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA J NOLTE
Regulation Number872.4200
Classification Product Code
EBW  
Date Received07/22/2009
Decision Date 12/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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