FDA 510(k) Application Details - K140602

Device Classification Name Material, Impression

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510(K) Number K140602
Device Name Material, Impression
Applicant 3M ESPE AG
ESPE PLATZ
SEEFELD D-82229 DE
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Contact RUEDIGER FRANKE
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Regulation Number 872.3660

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Classification Product Code ELW
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Date Received 03/10/2014
Decision Date 06/05/2014
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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