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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Powered
510(k) Number K854326
Device Name NO FLOSS FLOSSER
Applicant
Rgm Assoc.
P.O. Box 177
Los Altos,  CA  94022
Applicant Contact RENATO G MARTINEZ
Correspondent
Rgm Assoc.
P.O. Box 177
Los Altos,  CA  94022
Correspondent Contact RENATO G MARTINEZ
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received10/28/1985
Decision Date 04/23/1986
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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