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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 K970042
Device Name OOLI-U(TONGUE SCRAPER)
Applicant
Telefax Intl.
23704-5 El Toro Rd.
Suite 527
Lake Forest,  CA  92630
Applicant Contact UPEN SHAH
Correspondent
Telefax Intl.
23704-5 El Toro Rd.
Suite 527
Lake Forest,  CA  92630
Correspondent Contact UPEN SHAH
Regulation Number872.6855
Classification Product Code
LCN  
Date Received01/06/1997
Decision Date 03/14/1997
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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