FDA 510(k) Application Details - K092176

Device Classification Name Material, Impression

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510(K) Number K092176
Device Name Material, Impression
Applicant KERR CORPORATION
1717 WEST COLLINS AVENUE
ORANGE, CA 92867 US
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Contact Wendy Garman
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Regulation Number 872.3660

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Classification Product Code ELW
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Date Received 07/21/2009
Decision Date 01/28/2010
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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