FDA 510(k) Application Details - K040618

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K040618
Device Name Activator, Ultraviolet, For Polymerization
Applicant APOZA ENTERPRISE CO. LTD.
6 F,NO. 657, CHUNG-CHENG ROAD
HSIN-CHUANG CITY
TAIPEI HSIEN 242 TW
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Contact SHIH MIN-TEH
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 03/09/2004
Decision Date 03/25/2004
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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