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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 K844291
Device Name ARK TONGUE CLEANER
Applicant
Arkay Co.
P.O. Box 688
Coram,  NY  11727
Applicant Contact SANDRA TIWARI
Correspondent
Arkay Co.
P.O. Box 688
Coram,  NY  11727
Correspondent Contact SANDRA TIWARI
Regulation Number872.6855
Classification Product Code
LCN  
Date Received11/05/1984
Decision Date 11/23/1984
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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