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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 K851006
Device Name T-SWIPE -TONGUE CLEANER
Applicant
Kumar Ent.
1110 Decatur St.
Foster City,  CA  94404
Applicant Contact SUNIL K WADHWA
Correspondent
Kumar Ent.
1110 Decatur St.
Foster City,  CA  94404
Correspondent Contact SUNIL K WADHWA
Regulation Number872.6855
Classification Product Code
LCN  
Date Received03/12/1985
Decision Date 05/21/1985
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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