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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 K914962
Device Name FUN FLOSS
Applicant
Fun Floss Co.
P.O.Box 570365
Houston,  TX  77257
Applicant Contact WALTER G.MAYFIELD
Correspondent
Fun Floss Co.
P.O.Box 570365
Houston,  TX  77257
Correspondent Contact WALTER G.MAYFIELD
Regulation Number872.6390
Classification Product Code
JES  
Date Received11/05/1991
Decision Date 12/30/1991
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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