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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 K992270
Device Name MIRACLEBREATH TONGUE CLEANER
Applicant
STELLAR LABS, INC.
6637 SUPERIOR AVENUE, SUITE D
SARASOTA,  FL  34231
Applicant Contact HARLAN POMEROY III
Correspondent
STELLAR LABS, INC.
6637 SUPERIOR AVENUE, SUITE D
SARASOTA,  FL  34231
Correspondent Contact HARLAN POMEROY III
Regulation Number872.6855
Classification Product Code
LCN  
Date Received07/06/1999
Decision Date 09/23/1999
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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