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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 K884145
Device Name FLOSER PLUS
Applicant
Pacific Lin Intl., Co.
P.O. Box 3155
Alhambra,  CA  91803
Applicant Contact VICTOR LIN
Correspondent
Pacific Lin Intl., Co.
P.O. Box 3155
Alhambra,  CA  91803
Correspondent Contact VICTOR LIN
Regulation Number872.6390
Classification Product Code
JES  
Date Received10/03/1988
Decision Date 10/19/1988
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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