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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 K972644
Device Name BREATH-SO-FRESH TONGUE CLEANER
Applicant
Intl. Dental Design Specialists, Inc.
629 Ninth St.
Imperial Beach,  CA  91932
Applicant Contact CLIFFORD YUDELMAN
Correspondent
Intl. Dental Design Specialists, Inc.
629 Ninth St.
Imperial Beach,  CA  91932
Correspondent Contact CLIFFORD YUDELMAN
Regulation Number872.6855
Classification Product Code
LCN  
Date Received07/15/1997
Decision Date 09/11/1997
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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