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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 K981808
Device Name BREATHAID TONGUE SCRAPER
Applicant
Breathaid, LLC
Keenan Bldg., 3rd Floor
1330 Lady St.
Columbia,  SC  29211
Applicant Contact J. DOUGLAS NUNN, JR.
Correspondent
Breathaid, LLC
Keenan Bldg., 3rd Floor
1330 Lady St.
Columbia,  SC  29211
Correspondent Contact J. DOUGLAS NUNN, JR.
Regulation Number872.6855
Classification Product Code
LCN  
Date Received05/21/1998
Decision Date 08/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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