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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Powered
510(k) Number K903488
Device Name MERIDIEN DENTAL SYSTEMS
Applicant
Anco Merchandise Co., Ltd.
16f, #57 Fu Shing N. Rd.
Taipei, Taiwan, R.O.C.,  CN
Applicant Contact ANDREW HUANG
Correspondent
Anco Merchandise Co., Ltd.
16f, #57 Fu Shing N. Rd.
Taipei, Taiwan, R.O.C.,  CN
Correspondent Contact ANDREW HUANG
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received08/01/1990
Decision Date 07/09/1991
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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