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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 K952446
Device Name TONGUE CLEAN
Applicant
1-800-TONGUES, INC.
4739 UNIVERSITY WAY NE
SUITE 1602
SEATTLE,  WA  98105
Applicant Contact JOHN TUTTLE
Correspondent
1-800-TONGUES, INC.
4739 UNIVERSITY WAY NE
SUITE 1602
SEATTLE,  WA  98105
Correspondent Contact JOHN TUTTLE
Regulation Number872.6855
Classification Product Code
LCN  
Date Received05/25/1995
Decision Date 06/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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