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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Operating, Dental
510(k) Number K912997
Device Name MINIFLEX AND PERSONAL UNIT
Applicant
Dabi-Atlante America Corp.
5453 W. Waters Ave. Suite 200
Tampa,  FL  33634
Applicant Contact R FERNANDES
Correspondent
Dabi-Atlante America Corp.
5453 W. Waters Ave. Suite 200
Tampa,  FL  33634
Correspondent Contact R FERNANDES
Regulation Number872.4630
Classification Product Code
EAZ  
Date Received07/08/1991
Decision Date 10/30/1991
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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