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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 K931353
Device Name FLOSS PLUS
Applicant
Floss Plus, Inc.
S72 W13839 Woods Dr.
Muskego,  WI  53150
Applicant Contact TODD BUSHBERGER
Correspondent
Floss Plus, Inc.
S72 W13839 Woods Dr.
Muskego,  WI  53150
Correspondent Contact TODD BUSHBERGER
Regulation Number872.6390
Classification Product Code
JES  
Date Received03/17/1993
Decision Date 07/27/1993
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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