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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 Ave., Suite D
Sarasota,  FL  34231
Applicant Contact HARLAN POMEROY III
Correspondent
Stellar Labs, Inc.
6637 Superior Ave., 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
Predetermined Change
Control Plan Authorized		 No
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