FDA 510(k) Application Details - K021258

Device Classification Name Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile

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510(K) Number K021258
Device Name Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
Applicant GERM TERMINATOR CORPORATION
100 MAIN STREET,
SUITE 120
CONCORD, MA 01742 US
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Contact DAVID LINK
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Regulation Number 872.6855

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Classification Product Code MCF
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Date Received 04/19/2002
Decision Date 05/10/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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