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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 K871393
Device Name DR FLOSSER, FLOSSING AID/FLOSS HOLDING DEVICE
Applicant
Flossrite Corp.
6932 Gettysburg Pike
Fort Wayne,  IN  46804 -5697
Applicant Contact WAYNE T WOZNIAK,PHD
Correspondent
Flossrite Corp.
6932 Gettysburg Pike
Fort Wayne,  IN  46804 -5697
Correspondent Contact WAYNE T WOZNIAK,PHD
Regulation Number872.6390
Classification Product Code
JES  
Date Received04/07/1987
Decision Date 04/15/1987
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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