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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Denture, Mechanical
510(k) Number K881391
Device Name ULTRASONIC DENTURE CLEANER
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 Number872.3530
Classification Product Code
JER  
Date Received04/04/1988
Decision Date 08/26/1988
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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