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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 K821155
Device Name DENTAL FLOSS HOLDER
Applicant
Eric L. Smith
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Eric L. Smith
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.6390
Classification Product Code
JES  
Date Received04/26/1982
Decision Date 05/24/1982
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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