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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K922437
Device Name HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-270
Applicant
Dabi-Atlante America Corp.
5453 W. Waters Ave. Suite 200
Tampa,  FL  33634
Applicant Contact UBIRACI R FERNANDES
Correspondent
Dabi-Atlante America Corp.
5453 W. Waters Ave. Suite 200
Tampa,  FL  33634
Correspondent Contact UBIRACI R FERNANDES
Regulation Number872.4200
Classification Product Code
EFB  
Date Received05/22/1992
Decision Date 12/21/1992
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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