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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 K901408
Device Name THE TONGUE BRUSH
Applicant
GARRY LABORATORIES, INC.
1701 LIBRARY BLVD.
SUITE K
GREENWOOD,  IN  46142
Applicant Contact GARRY, DDS
Correspondent
GARRY LABORATORIES, INC.
1701 LIBRARY BLVD.
SUITE K
GREENWOOD,  IN  46142
Correspondent Contact GARRY, DDS
Regulation Number872.6855
Classification Product Code
LCN  
Date Received03/26/1990
Decision Date 05/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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