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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Floss, Dental
510(k) Number K964976
Device Name FLOSSBRUSH WITH FLUORIDE
Applicant
Flossbrush Interdental Cleaner and Applicator
450 Sutter St., Suite 2428
San Francisco,  CA  94108
Applicant Contact EDWARD L LOEV, D.M.D.
Correspondent
Flossbrush Interdental Cleaner and Applicator
450 Sutter St., Suite 2428
San Francisco,  CA  94108
Correspondent Contact EDWARD L LOEV, D.M.D.
Regulation Number872.6390
Classification Product Code
JES  
Date Received12/12/1996
Decision Date 05/06/1997
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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