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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 K860769
Device Name DENTAL FLOSS HOLDER
Applicant
Sewon Industry
P.O. Box 877
Orange,  CA  92668
Applicant Contact KI WON
Correspondent
Sewon Industry
P.O. Box 877
Orange,  CA  92668
Correspondent Contact KI WON
Regulation Number872.6390
Classification Product Code
JES  
Date Received03/03/1986
Decision Date 03/26/1986
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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