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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scraper, Tongue
510(k) Number K892388
Device Name THE TONGUE CLEANER
Applicant
Rajiv R. Shah
1435 Bussard Ct.
Arden Hills,  MN  55112
Applicant Contact RAJIV R SHAH
Correspondent
Rajiv R. Shah
1435 Bussard Ct.
Arden Hills,  MN  55112
Correspondent Contact RAJIV R SHAH
Regulation Number872.6855
Classification Product Code
LCN  
Date Received04/07/1989
Decision Date 06/16/1989
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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