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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
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