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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 K844989
Device Name FLO-PHORESIS - DESENSITIZER
Applicant
Eastco, Inc.
5276 NW 163 St.
Miami,  FL  33014
Applicant Contact PHILIP MCLEROY
Correspondent
Eastco, Inc.
5276 NW 163 St.
Miami,  FL  33014
Correspondent Contact PHILIP MCLEROY
Regulation Number872.4200
Classification Product Code
EGS  
Date Received12/26/1984
Decision Date 04/01/1985
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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