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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 K973424
Device Name ENFRESH TONGUE BRUSH
Applicant
ENFRESH PRODUCTS LLC.
555 13TH STREET, NW.
WASHINGTON,  DC  20004 -1109
Applicant Contact HOWARD M HOLSTEIN, ESG
Correspondent
ENFRESH PRODUCTS LLC.
555 13TH STREET, NW.
WASHINGTON,  DC  20004 -1109
Correspondent Contact HOWARD M HOLSTEIN, ESG
Regulation Number872.6855
Classification Product Code
LCN  
Date Received09/10/1997
Decision Date 12/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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