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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 K903712
Device Name FLOSSIE TOOTHFLOSS
Applicant
Flossie, Inc.
85 Cocasset St.
Foxboro,  MA  02035
Applicant Contact ROSEMARY M SMITH
Correspondent
Flossie, Inc.
85 Cocasset St.
Foxboro,  MA  02035
Correspondent Contact ROSEMARY M SMITH
Regulation Number872.6390
Classification Product Code
JES  
Date Received08/14/1990
Decision Date 09/05/1990
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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