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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 K874471
Device Name SUPER FLOSSER
Applicant
U.S. Pacific Corp.
P.O. Box 33040
Bloomfield Hills,  MI  48303
Applicant Contact CHEN, PH.D.
Correspondent
U.S. Pacific Corp.
P.O. Box 33040
Bloomfield Hills,  MI  48303
Correspondent Contact CHEN, PH.D.
Regulation Number872.6390
Classification Product Code
JES  
Date Received11/02/1987
Decision Date 01/28/1988
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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