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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 K885056
Device Name TWIXEL(TM)
Applicant
Fouts Development, Inc.
P.O. Box 6354
High Point,  NC  27260
Applicant Contact ROBERT L FOUTS
Correspondent
Fouts Development, Inc.
P.O. Box 6354
High Point,  NC  27260
Correspondent Contact ROBERT L FOUTS
Regulation Number872.6390
Classification Product Code
JES  
Date Received12/07/1988
Decision Date 01/04/1989
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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