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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 K961574
Device Name TONGUE SCRAPPER
Applicant
U.S. Dentek Corp.
1320 Industrial Ave.
Petaluma,  CA  94952
Applicant Contact JOHN JANSHEKI
Correspondent
U.S. Dentek Corp.
1320 Industrial Ave.
Petaluma,  CA  94952
Correspondent Contact JOHN JANSHEKI
Regulation Number872.6855
Classification Product Code
LCN  
Date Received04/23/1996
Decision Date 06/10/1996
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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