FDA 510(k) Application Details - K072181

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K072181
Device Name Activator, Ultraviolet, For Polymerization
Applicant SATELEC
124 GAITHER DRIVE
SUITE 140
MT. LAUREL, NJ 08054 US
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Contact STEVE SALESKY
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 08/06/2007
Decision Date 09/19/2007
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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