FDA 510(k) Application Details - K984247

Device Classification Name Activator, Ultraviolet, For Polymerization

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510(K) Number K984247
Device Name Activator, Ultraviolet, For Polymerization
Applicant ESPE DENTAL AG
ESPE PLATZ
SEEFELD, BAVARIA D-82229 DE
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Contact ANDREAS PETERMANN
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Regulation Number 872.6070

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Classification Product Code EBZ
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Date Received 11/27/1998
Decision Date 02/25/1999
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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