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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 K990344
Device Name ORALGIENE TONGUE CLEANER
Applicant
ORALGIENE USA, INC.
8460 HIGUERA ST.
CULVER CITY,  CA  90232
Applicant Contact BILL MUCKLEROY
Correspondent
ORALGIENE USA, INC.
8460 HIGUERA ST.
CULVER CITY,  CA  90232
Correspondent Contact BILL MUCKLEROY
Regulation Number872.6855
Classification Product Code
LCN  
Date Received02/04/1999
Decision Date 05/04/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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