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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 -3040
Applicant Contact CHEN, PH.D.
Correspondent
U.S. Pacific Corp.
P.O. Box 33040
Bloomfield Hills,  MI  48303 -3040
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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