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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 K021258
Device Name GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
Applicant
Germ Terminator Corporation
100 Main St.
Suite 120
Concord,  MA  01742
Applicant Contact DAVID LINK
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DONALD J SHERRATT
Regulation Number872.6855
Classification Product Code
MCF  
Date Received04/19/2002
Decision Date 05/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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