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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Denture, Over The Counter
510(k) Number K874805
Device Name TATUNG'S DENTURE CLEANING SOLUTION
Applicant
Tatung Company of America, Inc.
2850 El Presidio St.
Long Beach,  CA  90810
Applicant Contact JULIA CASSIDY
Correspondent
Tatung Company of America, Inc.
2850 El Presidio St.
Long Beach,  CA  90810
Correspondent Contact JULIA CASSIDY
Regulation Number872.3520
Classification Product Code
EFT  
Date Received11/23/1987
Decision Date 02/16/1988
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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