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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 K983683
Device Name UNIK TONGUE CLEANER
Applicant
Unik Products, Inc.
Salibury & Cambria Llp
42 Delaware Ave., Suite 300
Buffalo,  NY  14202
Applicant Contact HARRY E WERNER
Correspondent
Unik Products, Inc.
Salibury & Cambria Llp
42 Delaware Ave., Suite 300
Buffalo,  NY  14202
Correspondent Contact HARRY E WERNER
Regulation Number872.6855
Classification Product Code
LCN  
Date Received10/20/1998
Decision Date 01/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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