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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
510(k) Number K003517
Device Name OTRES TOOTHBRUSH SANITIZER MODEL TB100W
Applicant
Otres, LLC
4225 Naperville Rd.
Suite 155
Lisle,  IL  60542
Applicant Contact DAVID BUDDINGH
Correspondent
Otres, LLC
4225 Naperville Rd.
Suite 155
Lisle,  IL  60542
Correspondent Contact DAVID BUDDINGH
Regulation Number872.6855
Classification Product Code
MCF  
Date Received11/14/2000
Decision Date 06/06/2001
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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