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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 K855113
Device Name FLOSS HOLDER (PLASTIC)
Applicant
Pacific Union Dental, Inc.
P.O. Box 2025
Silver Spring,  MD  20902
Applicant Contact KENNETH WOO
Correspondent
Pacific Union Dental, Inc.
P.O. Box 2025
Silver Spring,  MD  20902
Correspondent Contact KENNETH WOO
Regulation Number872.6390
Classification Product Code
JES  
Date Received12/23/1985
Decision Date 03/06/1986
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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