FDA 510(k) Application Details - K021374

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K021374
Device Name Activator, Ultraviolet, For Polymerization
Applicant TOEI ELECTRIC CO., LTD.
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 05/01/2002
Decision Date 05/30/2002
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 N
Expedited Review



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