FDA 510(k) Application Details - K023662

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

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510(K) Number K023662
Device Name Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
Applicant HWADONG INTERNATIONAL COMPANY LTD.
501 S. ANDREWS AVE.
FT. LAUDERDALE, FL 33301 US
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Contact MARIAN COCHRAN
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Regulation Number 872.6855

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Classification Product Code MCF
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Date Received 10/31/2002
Decision Date 05/28/2003
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 N
Expedited Review



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