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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 K980842
Device Name COPPER TONGUE SCRAPER
Applicant
Ontel Products Corp.
2 Daniel Rd. E.
Fairfield,  NJ  07004
Applicant Contact MIKE K LAKHIANI
Correspondent
Ontel Products Corp.
2 Daniel Rd. E.
Fairfield,  NJ  07004
Correspondent Contact MIKE K LAKHIANI
Regulation Number872.6855
Classification Product Code
LCN  
Date Received03/04/1998
Decision Date 05/20/1998
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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