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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 K862694
Device Name FLOSS CARD
Applicant
Floss Card Co.
230 Fifth Ave.,
New York,  NY  10001
Applicant Contact ROBERT ENDELSON
Correspondent
Floss Card Co.
230 Fifth Ave.,
New York,  NY  10001
Correspondent Contact ROBERT ENDELSON
Regulation Number872.6390
Classification Product Code
JES  
Date Received07/15/1986
Decision Date 08/06/1986
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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